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Pennsylvania Statutes Title 40 P.S. Insurance § 991.2164g. External review of experimental or investigational treatment adverse benefit determinations
Current as of January 01, 2025 | Updated by Findlaw Staff
(a) Request for review.--
(1) Within four months of the date of receipt of a notice of an adverse benefit determination or final adverse benefit determination under section 2164.2 1 that involves a denial of coverage based on a determination that the health care services recommended or requested are experimental or investigational, a covered person, or the covered person's authorized representative, may file a request for external review with the department.
(2) A covered person, or the covered person's authorized representative, may make an oral request for expedited external review of the adverse benefit determination or final adverse benefit determination under paragraph (1) if the covered person's treating health care provider certifies in writing that the recommended or requested health care services that are the subject of the request would be significantly less effective if not promptly initiated. Upon receipt of a request for an expedited external review, the department shall notify the insurer within 24 hours.
(3) With respect to notice of an insurer's eligibility determination:
(i) Upon notice of the request for expedited external review, the insurer shall immediately determine whether the request meets the requirements for review under section 2164.5(b). 2 The insurer shall, within 24 hours, notify the department, the covered person and, if applicable, the covered person's authorized representative of the insurer's eligibility determination.
(ii) The department may specify the form for the insurer's notice of initial determination under subparagraph (i) and any supporting information to be included in the notice.
(iii) The notice of initial determination under subparagraph (i) shall include a statement informing the covered person and, if applicable, the covered person's authorized representative of an insurer's initial determination that the external review request is ineligible for review and that the external review request may be appealed to the department.
(4) Notwithstanding an insurer's initial determination, the department may decide that a request is eligible for external review under section 2164.5(b) and require that the request be referred for external review. The department's decision shall be made in accordance with the terms of the covered person's health insurance policy and shall be subject to all applicable provisions of this subdivision. The department's decision shall be binding on the insurer and the covered person and may be appealed to the commissioner. Consideration of an appeal may not delay or terminate the external review.
(5) Upon receipt of a notice that the expedited external review request meets the reviewability requirements of subsection (b)(2), the department shall, within 24 hours, assign an IRO to review the expedited request from the list of approved IROs compiled and maintained by the department under section 2164.9 3 and notify the insurer of the name of the assigned IRO. The insurer, or a utilization review organization designated by the insurer, shall then provide or transmit all necessary documents and information considered in making the adverse benefit determination or final adverse benefit determination to the assigned IRO:
(i) Electronically.
(ii) By telephone.
(iii) By facsimile.
(iv) By any other available expeditious method.
(b) Preliminary review request.--
(1) Except for a request for an expedited external review made under subsection (a)(2), within one business day of the date of receipt of the request for external review, the department shall notify the insurer of the department's receipt of the request.
(2) Within five business days of the date of receipt of the notice sent under paragraph (1), the insurer shall conduct and complete a preliminary review of the request to determine whether:
(i) The individual is or was a covered person under the health insurance policy at the time the health care services were recommended or requested or, in the case of a retrospective review, was a covered person under the health insurance policy at the time the health care services were provided.
(ii) The recommended or requested health care service that is the subject of the adverse benefit determination or final adverse benefit determination:
(A) Is a covered benefit under the covered person's health insurance policy, except for the insurer's determination that the health care service is experimental or investigational for a particular medical condition.
(B) Is not explicitly listed as an excluded benefit under the covered person's health insurance policy.
(iii) The covered person's treating health care provider has certified that one of the following situations is applicable:
(A) Standard health care services have not been effective in improving the condition of the covered person.
(B) Standard health care services are not medically appropriate for the covered person.
(C) There are no available standard health care services covered under the health insurance policy that are more beneficial than the recommended or requested health care services described in subparagraph (iv).
(iv) The covered person's treating health care provider either:
(A) Has recommended health care services that the health care provider certifies, in writing, are likely to be more beneficial to the covered person, in the health care provider's opinion, than available standard health care services.
(B) Has certified in writing that scientifically valid studies using accepted protocols demonstrate that the health care services requested by the covered person who is the subject of the adverse benefit determination or final adverse benefit determination are likely to be more beneficial to the covered person than any available standard health care services when the treating health care provider 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.
(v) The covered person has exhausted the insurer's internal claims and appeal process under section 2164, 4 unless the covered person is not required to exhaust the insurer's internal appeal process under section 2164.4. 5
(vi) The covered person has provided all the information and forms required by the department that are necessary to process an external review, including the release form provided under section 2164.2(b).
(c) Notice of initial determination.--
(1) Within one business day of completion of the preliminary review, the insurer shall notify the department and covered person and, if applicable, the covered person's authorized representative in writing whether the request is complete and eligible for external review.
(2) If the request:
(i) Is not complete, the insurer shall inform the covered person and, if applicable, the covered person's authorized representative and the department in writing and include in the notice what information or materials are needed to make the request complete.
(ii) Is not eligible for external review, the insurer shall inform the covered person and, if applicable, the covered person's authorized representative and the department in writing and include in the notice the reasons for the request's ineligibility.
(3) Notification provided under paragraph (2) shall be provided in a form specified by the department and include a statement informing the covered person and, if applicable, the covered person's authorized representative of an insurer's initial determination that the request is ineligible for external review and that the external review request may be appealed to the department.
(4) Notwithstanding an insurer's initial determination that the request is ineligible for review, the department may determine, based upon the terms of the covered person's health insurance policy, that the request is eligible for external review under section 2164.5. The determination shall be binding on the insurer and the covered person and may be appealed to the commissioner. Consideration of the appeal may not delay or terminate the external review.
(5) When a request is determined to be eligible for external review, the insurer shall notify the department, the covered person and, if applicable, the covered person's authorized representative.
(d) Procedure for review of requests eligible for external review.--
(1) Within one business day of the date of receipt of notice that a request is eligible for external review following the preliminary review conducted under subsection (a)(4) or (c)(4), the department shall:
(i) Assign an IRO to conduct the external review from the list of approved IROs compiled and maintained by the department under section 2164.9 and notify the insurer of the name of the assigned IRO.
(ii) Notify in writing the covered person and, if applicable, the covered person's authorized representative of the request's eligibility and acceptance for external review. The notification shall include a statement that the covered person, or the covered person's authorized representative, may submit in writing to the assigned IRO, within five business days of the date of receipt of the notice provided under subparagraph (i), additional information that the IRO shall consider when conducting the external review. The IRO may accept and consider additional information submitted after five business days.
(2) Within one business day of the receipt of the notice of assignment to conduct the external review under paragraph (1), the assigned IRO shall:
(i) Select one or more clinical reviewers under paragraph (3) to conduct the external review.
(ii) Based on the opinion or opinions of the clinical reviewer or reviewers, make a decision to uphold or reverse the adverse benefit determination or final adverse benefit determination.
(3) In selecting a clinical reviewer, the assigned IRO shall select a physician or other health care provider who meets the minimum qualifications described in section 2164.10 6 and, through clinical experience in the past three years, has expertise in the treatment of the covered person's condition and is knowledgeable about the recommended or requested health care service. The covered person, the covered person's authorized representative and, if applicable, the insurer may not choose or control the choice of the physician or other health care provider to be selected to conduct the external review.
(4) In accordance with subsection (h), each clinical reviewer shall provide a written opinion to the assigned IRO regarding whether the recommended or requested health care service should be covered.
(5) The assigned clinical reviewer is not bound by a decision or conclusion reached during the insurer's internal claims and appeal process under section 2164.
(e) Forwarding of required documents.--
(1) Within five business days of the date of receipt of the notice provided under subsection (d)(1), the insurer, or a utilization review organization designated by the insurer, shall provide to the assigned IRO the documents and information considered in making the adverse benefit determination or the final adverse benefit determination.
(2) Except as provided in paragraph (3), failure by the insurer, or by a utilization review organization designated by the insurer, to provide the documents and information within the time period specified in paragraph (1) may not delay the conduct of the external review.
(3) If the insurer, or a utilization review organization designated by the insurer, fails to provide the documents and information within the time period specified in paragraph (1), the assigned IRO may terminate the external review and make a decision to reverse the adverse benefit determination or final adverse benefit determination. Within 24 hours upon making the decision, the IRO shall notify the department, the insurer, the covered person and, if applicable, the covered person's authorized representative.
(f) Review of information.--
(1) Each clinical reviewer selected under subsection (d) shall review all of the information and documents received under subsection (e) and other information submitted in writing by the covered person or covered person's authorized representative in response to the notice provided under subsection (d)(1)(ii).
(2) Within one business day of receipt of information submitted by the covered person or covered person's authorized representative under subsection (d)(1)(ii), the assigned IRO shall forward the information to the insurer.
(g) Reconsideration by insurer.--
(1) Upon receipt of the information, if any, required to be forwarded under subsection (f)(2), the insurer may reconsider an adverse benefit determination or final adverse benefit determination that is the subject of the external review.
(2) Reconsideration by the insurer of an adverse benefit determination or final adverse benefit determination under paragraph (1) may not delay or terminate the external review.
(3) The external review may be terminated without an IRO determination only if the insurer decides, upon completion of reconsideration, to reverse the adverse benefit determination or final adverse benefit determination and provide coverage or payment for the recommended health care service that is the subject of the external review.
(4) Within one business day of making the decision to reverse the insurer's adverse benefit determination or final adverse benefit determination, as provided in paragraph (3), the insurer shall notify the department, the assigned IRO, the covered person and, if applicable, the covered person's authorized representative in writing of the insurer's decision.
(5) The assigned IRO shall terminate the external review upon receipt of the notice from the insurer under paragraph (4).
(h) Clinical review process.--
(1) Except as provided in paragraph (3), within 20 days of being selected in accordance with subsection (d) to conduct the external review, each clinical reviewer shall provide an opinion to the assigned IRO regarding whether the recommended or requested health care service should be covered.
(2) Except for an opinion provided under paragraph (3), a clinical reviewer's opinion shall be in writing and include the following information:
(i) A description of the covered person's medical condition.
(ii) A description of the indicators relevant to determining whether there is sufficient evidence to demonstrate that:
(A) The recommended or requested health care service is more likely than not to be beneficial to the covered person than any available standard health care service.
(B) The adverse risks of the recommended or requested health care service would not be substantially increased over the adverse risks of available standard health care service.
(iii) A description and analysis of medical or scientific evidence considered in reaching the opinion.
(iv) A description and analysis of an evidence-based standard.
(v) Information on whether the reviewer's rationale for the opinion is based on subsection (i)(5)(i) or (ii).
(3) The following shall apply:
(i) For an expedited external review, a clinical reviewer shall provide an opinion orally or in writing to the assigned IRO as expeditiously as the covered person's medical condition or circumstances require, but in no event more than five calendar days after being selected in accordance with subsection (d).
(ii) If the opinion provided under subparagraph (i) is not in writing, within 48 hours of the date the opinion was provided, the clinical reviewer shall provide written confirmation of the opinion to the assigned IRO and include the information required under paragraph (2).
(i) Factors to be considered.--In addition to the documents and information provided under subsection (a)(2) or (e), a clinical reviewer selected under subsection (d), to the extent the information or documents are available and the reviewer considers appropriate, shall consider the following in reaching an opinion under subsection (h):
(1) The covered person's medical records.
(2) The attending health care provider's recommendation.
(3) Consulting reports from appropriate health care providers and other documents submitted by the insurer, the covered person and, if applicable, the covered person's authorized representative or treating provider.
(4) The terms of coverage under the covered person's health insurance policy to ensure that the IRO's decision is not contrary to the terms.
(5) Whether either of the following is satisfied:
(i) The recommended or requested health care service has been approved by the United States Food and Drug Administration, if applicable, for the condition.
(ii) Medical or scientific evidence or evidence-based standards demonstrate that:
(A) The expected benefit of the recommended or requested health care service is more likely than not to be beneficial to the covered person than any available standard health care service.
(B) The adverse risks of the recommended or requested health care service would not be substantially increased over the adverse risks of an available standard health care service.
(j) Notice of decision.--
(1) Except as required under section 2164.6(e) 7 for an expedited external review, within 20 days of the date the assigned IRO receives the opinion of a clinical reviewer, the assigned IRO shall provide written notice of the assigned IRO's decision to uphold or reverse the adverse benefit determination to:
(i) The covered person.
(ii) If applicable, the covered person's authorized representative.
(iii) The insurer.
(iv) The department.
(2) If a majority of the clinical reviewers recommend that:
(i) The recommended or requested health care service be covered, the IRO shall make a decision to reverse the insurer's adverse benefit determination or final adverse benefit determination.
(ii) The recommended or requested health care service not be covered, the IRO shall make a decision to uphold the insurer's adverse benefit determination or final adverse benefit determination.
(3) If the clinical reviewers are evenly divided as to whether the recommended or requested health care service should be covered:
(i) The IRO shall obtain the opinion of an additional clinical reviewer in order for the IRO to make a decision based on the opinions of a majority of the clinical reviewers.
(ii) The additional clinical reviewer selected 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 may not extend the time within which the assigned IRO is required to make a decision.
(4) The IRO shall include the following in the notice provided under paragraph (1):
(i) A general description of the reason for the request for external review.
(ii) The written opinion of each clinical reviewer, including the recommendation of each clinical reviewer as to whether the recommended or requested health care service should be covered and the rationale for the reviewer's recommendation.
(iii) The date the IRO was assigned by the department to conduct the external review.
(iv) The date of the external review.
(v) The date of the IRO's decision.
(vi) The principal reason or reasons for the IRO's decision.
(vii) The rationale for the IRO's decision.
(5) Upon receipt of a notice of a decision under paragraph (1) reversing the adverse benefit determination or final adverse benefit determination, the insurer shall, within 24 hours, approve the coverage that was the subject of the adverse benefit determination or final adverse benefit determination.
(k) Assignment of IRO.--The department shall assign, on a random basis, an approved IRO among those qualified to conduct the particular external review based on the nature of the health care service that is the subject of the adverse benefit determination or final adverse benefit determination and shall consider the conflict-of-interest concerns under section 2164.10(d).
1
40 P.S. § 991.2164b.
2
40 P.S. § 991.2164e.
3
40 P.S. § 991.2164i.
4
40 P.S. § 991.2164.
5
40 P.S. § 991.2164d.
6
40 P.S. § 991.2164j.
7
40 P.S. § 991.2164f.
Cite this article: FindLaw.com - Pennsylvania Statutes Title 40 P.S. Insurance § 991.2164g. External review of experimental or investigational treatment adverse benefit determinations - last updated January 01, 2025 | https://codes.findlaw.com/pa/title-40-ps-insurance/pa-st-sect-40-991-2164g/
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