2023 Laws of Puerto Rico › TITLE TWENTY-SIX - Insurance (§§ 101 — 10377) › Subtitle 3 - Puerto Rico Health Insurance Code (§§ 9001 — 10377) › Chapter 126 - External Review (§§ 9501 — 9517) › § 9510 - External review of experimental or investigational treatment adverse determinations

(a)
(1) Not later than one hundred twenty (120) days after the date of receipt of a notice of an adverse determination or final adverse determination that involves a denial of a healthcare service or treatment recommended or requested based on a determination that such service or treatment is experimental or investigational, a covered person or enrollee may file a request for external review with the Commissioner.
(2)
(A) A covered person or enrollee may make an oral request for an expedited external review of the adverse determination or final adverse determination that involves a denial of a healthcare service or treatment recommended or requested based on a determination that such service or treatment is experimental or investigational, provided that the covered person or enrollee's treating physician certifies, in writing, that the recommended or requested healthcare service or treatment that was denied would be significantly less effective if not promptly initiated.
(B) Upon receipt of a request for an expedited external review pursuant to paragraph (A) above, the Commissioner immediately shall notify the health insurance organization or issuer involved of the aforementioned request.
(C)
(i) Upon receipt of a copy of the request, the health insurance organization or issuer immediately shall determine whether the request meets the reviewability requirements of subsection (b)(2) of this section and notify the Commissioner and the covered person or enrollee of its determination indicating whether the request is eligible for external review.
(ii) The Commissioner may specify the form and content of the initial determination referred to in subparagraph (i) above.
(iii) If the health insurance organization or issuer determines, as a result of the preliminary review conducted in accordance with subparagraph (i) of this paragraph, that the request is ineligible for external review, the notice provided to the covered person or enrollee shall include a statement informing him/her that the health insurance organization or issuer's determination of ineligibility may be appealed to the Commissioner.
(D)
(i) The Commissioner may determine that a request is eligible for external review notwithstanding a health insurance organization or issuer's initial determination to the contrary.
(ii) The Commissioner shall make a determination that a request is eligible for external review, notwithstanding a health insurance organization or issuer's initial determination to the contrary, in accordance with the terms of the covered person or enrollee's health plan and shall be subject to all applicable provisions of this chapter.
(E) Upon receipt of the notice from the health insurance organization or issuer that the expedited external review request meets the reviewability requirements, the Commissioner immediately shall assign an independent review organization to conduct an expedited external review and notify the health insurance organization or issuer of the name of the assigned independent review organization, and notify in writing the covered person or enrollee that his/her request is eligible and was accepted for expedited external review.
(F) Upon receipt of the notice from the Commissioner of the name of the assigned independent review organization, the health insurance organization or issuer shall provide or transmit all necessary documents and information considered in making the adverse determination or final adverse determination subject to expedited external review electronically or by any other available expeditious method.
(b)
(1) Except for a request for an expedited external review made pursuant to subsection (a)(2) of this section, not later than one (1) business day after the date of receipt of the request for an external review that involves a denial of a healthcare service or treatment recommended or requested based on a determination that such service or treatment is experimental or investigational, the Commissioner shall notify the health insurance organization or issuer involved with a copy of the request.
(2) Upon receipt of the notice of the request for external review, the health insurance organization or issuer shall have five (5) businesses days to conduct a preliminary review of the request to determine whether:
(A) The individual is or was a covered person or enrollee in the health plan at the time the denied healthcare service or treatment was recommended or requested or, in the case of a retrospective review, was a covered person or enrollee in the health plan at the time the healthcare service or treatment was provided.
(B) The 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 or enrollee's health plan except for the health insurance organization or issuer's determination that the service or treatment is experimental or investigational, and
(ii) is not explicitly listed as an excluded benefit under the covered person or enrollee's health plan.
(C) The covered person or enrollee's treating physician has certified that one of the following situations is applicable:
(i) Standard healthcare services or treatments have not been effective in improving the condition of the covered person or enrollee;
(ii) standard healthcare services or treatments are not medically appropriate for the covered person or enrollee, or
(iii) there is no available standard healthcare service or treatment covered by the health plan that is more beneficial than the recommended or requested healthcare service or treatment.
(D) The covered person or enrollee'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 or enrollee, in the physician's opinion, than any available standard healthcare services or treatments, or
(ii) the covered person or enrollee's treating physician, who is qualified to practice in the area of medicine appropriate to treat the health condition in question, has certified in writing that scientifically valid studies using accepted protocols demonstrate that the healthcare service or treatment requested by the covered person or enrollee is likely to be more beneficial than any available standard healthcare services or treatments.
(E) The covered person or enrollee has exhausted the health insurance organization or issuer's internal grievance process, unless he/she is not required to exhaust such remedy pursuant to § 9507 of this title.
(F) The covered person or enrollee 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 § 9505(b)(3) of this title.
(c)
(1) Not later than one (1) business day after completion of the preliminary review pursuant to subsection (b)(2) of this Section, the health insurance organization or issuer shall notify the Commissioner and the covered person or enrollee 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 insurance organization or issuer shall inform in writing the Commissioner and the covered person or enrollee and include what information or materials are needed to make the request complete, or
(B) is not eligible for external review, the health insurance organization or issuer shall inform the covered person or enrollee and the Commissioner in writing and include the reasons for its ineligibility.
(3)
(A) The Commissioner may specify the form and content of the health insurance organization or issuer's notice of initial determination referred to in clause (2) of this subsection.
(B) If the health insurance organization or issuer determines, as a result of the preliminary review conducted in accordance with subsection (b)(2) of this section, that an external review request is ineligible for external review, the notice provided to the covered person or enrollee shall include a statement informing him/her that the health insurance organization or issuer's determination of ineligibility may be appealed to the Commissioner.
(4)
(A) The Commissioner may determine that a request is eligible for external review notwithstanding a health insurance organization or issuer's initial determination to the contrary.
(B) In making a determination that a request is eligible for external review notwithstanding a health insurance organization or issuer's initial determination to the contrary, the Commissioner's decision shall be made in accordance with the terms of the health plan and shall be subject to all applicable provisions of this chapter.
(5) Whenever a health insurance organization or issuer determines that a request for external review is eligible for such purposes, it shall notify the Commissioner and the covered person or enrollee of such determination.
(d)
(1) Not later than one (1) business day after the receipt of the notice from the health insurance organization or issuer that the external review request is eligible for external review, the Commissioner shall:
(A) Assign an independent review organization to conduct the external review and notify the health insurance organization or issuer of the name of the assigned independent review organization, and
(B) notify in writing the covered person or enrollee of the request's eligibility and acceptance for external review.
(2) The Commissioner shall include in the notice of request acceptance for external review provided to the covered person or enrollee a statement that the covered person or enrollee may submit in writing to the independent review organization within five (5) business days following the date of receipt of the notice, any additional information that the independent review organization shall consider when conducting the external review. The independent review organization shall not be required to, but may, accept and consider additional information submitted after the five (5) business days provided herein.
(3) Not later than one (1) business day after the receipt of the notice of assignment to conduct the external review, the independent review organization shall:
(A) Select one (1) or more clinical reviewers, as appropriate, to conduct the external review; and
(4)
(A) In selecting clinical reviewers, the independent review organization shall select physicians or other healthcare professionals who meet the minimum qualifications described in § 9513(b) of this title and, through clinical experience in the past three (3) years, are experts in the treatment of the covered person or enrollee's condition and knowledgeable about the recommended or requested healthcare service or treatment.
(B) Neither the covered person or enrollee nor the health insurance organization or issuer shall choose or control the choice of the physicians or other healthcare professionals to be selected as clinical reviewers to conduct the external review.
(5) In accordance with subsection (h) of this section, each clinical reviewer shall provide a written opinion to the independent review organization on whether the recommended or requested healthcare service or treatment should be covered.
(6) In reaching an opinion, clinical reviewers shall not be bound by any decisions or conclusions reached during the health insurance organization or issuer's utilization review process or internal grievance process.
(e)
(1) Not later than five (5) business days after the date of receipt of the notice on the designated utilization review organization, the health insurance organization or issuer shall provide the documents and any information considered in making the adverse determination or the final adverse determination subject of the review.
(2) Except as provided in clause (3) of this subsection, failure by the health insurance organization or issuer to provide the documents and information within five business (5) days as specified in s clause (1) of this subsection, shall not delay the conduct of the external review.
(3)
(A) If the health insurance organization or issuer has failed to provide the required documents and information within five (5) business days as specified in clause (1) of this subsection, the independent review organization may terminate the external review and make a decision to reverse the adverse determination or final adverse determination subject of the review.
(B) If the independent review organization decides to reverse the adverse determination or the final adverse determination under paragraph (A) of this clause, it shall immediately notify the covered person or enrollee, the health insurance organization or issuer, and the Commissioner.
(f)
(1) Each clinical reviewer shall review all of the information and documents received from the health insurance organization or issuer and any other information submitted in writing by the covered person or enrollee.
(2) If the independent review organization receives any information from the covered person or enrollee, the independent review organization shall forward the information to the health insurance organization or issuer not later than one (1) business day after the receipt thereof.
(g)
(1) Upon receipt of the information provided in subsection (f)(2) of this section, the health insurance organization or issuer may reconsider its adverse determination or final adverse determination that is the subject of the external review.
(2) Reconsideration by the health insurance organization or issuer of its adverse determination or final adverse determination shall not delay or terminate the external review.
(3) The external review may terminated only if the health insurance organization or issuer decides, upon completion of its reconsideration, to reverse its adverse determination or final adverse determination and provide coverage or payment for the 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, the health insurance organization or issuer shall notify, in writing, the covered person or enrollee, the assigned independent review organization, and the Commissioner of its decision.
(B) The independent review organization shall terminate the external review upon receipt of the notice from the health insurance organization or issuer sent pursuant to paragraph (A) of this clause.
(h)
(1) Except as provided in clause (3) of this subsection, not later than twenty (20) days after being selected to conduct the external review, each clinical reviewer shall provide an opinion to the independent review organization on whether the recommended or requested healthcare service or treatment should be covered.
(2) Except for an opinion provided pursuant to clause (3) of this subsection, each clinical reviewer's opinion shall be in writing and include the following information:
(A) A description of the covered person or enrollee's medical condition;
(B) a description of the indicators relevant to determining whether there is sufficient evidence to demonstrate that the recommended or requested healthcare service or treatment is more likely than not to be beneficial to the covered person or enrollee than any available standard healthcare services or treatments and that the 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 considered in reaching the opinion;
(D) a description and analysis of any evidence-based standard, taken into account in reaching an opinion, and
(E) information on whether the reviewer's rationale for the opinion is based on paragraph (A) or (B) of subsection (i)(5) of this section.
(3)
(A) For an expedited external review, each clinical reviewer shall provide an opinion orally or in writing to the independent review organization as expeditiously as the covered person or enrollee's medical condition or circumstances requires, but in no event more than five (5) calendar days after being selected to conduct the external review.
(B) If the opinion of the clinical reviewer was not in writing, within two (2) days following the date the opinion was provided, the clinical reviewer shall provide written confirmation of the opinion to the independent review organization and include the information required under clause (2) of this subsection.
(i) In addition to the documents and information provided pursuant to subsection (a)(2)(F) or subsection (e)(1) of this section, each clinical reviewer, to the extent the information or documents are available and the reviewer considers appropriate, shall consider the following in reaching an opinion:
(1) The covered person or enrollee's pertinent medical records;
(2) the covered person or enrollee's attending physician or healthcare professional's recommendation;
(3) consulting reports from appropriate healthcare professionals and other documents submitted by the health insurance organization or issuer, covered person or enrollee, or his/her treating physician or healthcare professional;
(4) the terms of coverage under the covered person or enrollee's health plan, and
(5) the applicable alternative, if applicable, of the following:
(A) The recommended or requested healthcare service or treatment has been approved by the federal Food and Drug Administration (FDA), if applicable, for the condition of the covered person or enrollee, or
(B) Medical or scientific evidence or evidence-based standards demonstrate that the expected benefits of the recommended or requested healthcare service or treatment is more likely than not to be beneficial to the covered person or enrollee than any available standard healthcare service or treatment and that the 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 paragraph (B) of this clause, not later than twenty (20) days after the date it receives the opinion of each clinical reviewer, the independent review organization, in accordance with clause (2) of this subsection, shall make a decision and provide written notice of the decision to:
(i) The covered person or enrollee;
(ii) the health insurance organization or issuer, and
(iii) the Commissioner.
(B)
(i) For an expedited external review, not later than forty-eight (48) hours after the date it receives the opinion of each clinical reviewer, the independent review organization shall make a decision and provide notice of the decision orally or in writing to the covered person or enrollee, the health insurance organization or issuer, and the Commissioner.
(ii) If notice of the determination was not in writing, not later than two (2) days after the date of providing that notice, the independent review organization shall provide written confirmation of the decision to the covered person or enrollee, the health insurance organization or issuer, and the Commissioner and shall include the information set forth in clause (3) of this subsection.
(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 insurance organization or issuer's adverse determination or final adverse determination subject of the review.
(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 insurance organization or issuer'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.
(ii) If the need to select an additional clinical reviewer arises in accordance with the preceding item, such additional clinical reviewer shall use the same information to reach an opinion as the clinical reviewers who have already submitted their opinions.
(iii) The selection of the additional clinical reviewer shall not extend the time within which the independent review organization is required to make a decision based on the opinions of the clinical reviewers selected.
(3) The independent review organization shall include in the notice:
(A) A general description of the reason for the request for external review;
(B) the written opinion of each clinical reviewer, including the recommendation of each clinical reviewer as to whether the recommended or requested healthcare service or treatment should be covered and the rationale for the reviewer's recommendation;
(C) the date the independent review organization was assigned by the Commissioner to conduct the external review;
(D) the date the external review was conducted;
(E) the date of its decision;
(F) the principal reason or reasons for its decision, and
(G) the rationale for its decision.
(4) If the independent review organization reverses the adverse determination or final adverse determination, the health insurance organization or issuer involved immediately shall approve coverage or payment of the healthcare service or treatment subject of the review.
(k) The assignment by the Commissioner of an 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 in question based on the nature of the healthcare service that is the subject of the adverse determination or final adverse determination and other circumstances, including potential conflict of interests.
History —Aug. 29, 2011, No. 194, added as § 28.100 on Aug. 23, 2012, No. 203, § 7, eff. 90 days after Aug. 23, 2012.