3923.77 Establishing reasonable external, independent review process - public employee benefit plan.
(A) Each public employee benefit plan shall establish a reasonable external review process to examine the plan’s coverage decisions for plan members who meet all of the following criteria:
(1) The plan member has a terminal condition that, according to the current diagnosis of the plan member’s physician, has a high probability of causing death within two years.
(2) The plan member requests a review not later than one hundred eighty days after receipt by the plan member of notice from the plan of the adverse decision.
(3) The plan member’s physician certifies that the plan member has the condition described in division (A)(1) of this section and any of the following situations are applicable:
(a) Standard therapies have not been effective in improving the condition of the plan member.
(b) Standard therapies are not medically appropriate for the plan member.
(c) There is no standard therapy covered by the plan that is more beneficial than therapy described in division (A)(4) of this section.
(4) The plan member’s physician has recommended a drug, device, procedure, or other therapy that the physician certifies, in writing, is likely to be more beneficial to the plan member, in the physician’s opinion, than standard therapies, or the plan member has requested a therapy that has been found in a preponderance of peer-reviewed published studies to be associated with effective clinical outcomes for the same condition.
(5) The plan member has been denied coverage by the plan for a drug, device, procedure, or other therapy recommended or requested pursuant to division (A)(4) of this section, and has exhausted all internal appeals.
(6) The drug, device, procedure, or other therapy, for which coverage has been denied, would be a covered health care service except for the plan’s determination that the drug, device, procedure, or other therapy is experimental or investigational.
(B) A review shall be requested in writing, except that if the plan member’s physician determines that a therapy would be significantly less effective if not promptly initiated, the review may be requested orally or by electronic means. When an oral or electronic request for review is made, written confirmation of the request shall be submitted to the plan not later than five days after the oral or written request is submitted. For an expedited review, the plan member’s provider must certify that the requested or recommended therapy would be significantly less effective if not promptly initiated.
(C) The external review process established by a plan shall meet all of the following criteria:
(1) Except as provided in division (E) of this section, the process shall afford all plan members who meet the criteria set forth in division (A) of this section the opportunity to have the plan’s decision to deny coverage of the recommended or requested therapy reviewed under the process. Each eligible plan member shall be notified of that opportunity within thirty business days after the plan denies coverage.
(2) The review shall be conducted by an independent review organization assigned by the superintendent of insurance under section 3901.80 of the Revised Code. The independent review organization shall select a panel to conduct the review, which panel shall be composed of at least three physicians or other providers who, through clinical experience in the past three years, are experts in the treatment of the plan member’s medical condition and knowledgeable about the recommended or requested therapy. If the independent review organization retained by the plan is an academic medical center, the panel may include experts affiliated with or employed by the academic medical center.
In either of the following circumstances, an exception may be made to the requirement that the review be conducted by an expert panel composed of a minimum of three physicians or other providers:
(a) A review may be conducted by an expert panel composed of only two physicians or other providers if a plan member has consented in writing to a review by the smaller panel.
(b) A review may be conducted by a single expert physician or other provider if only the expert physician or other provider is available for the review.
(3) Neither the plan nor the plan member shall choose, or control the choice of, the physician or other provider experts.
(4) The selected experts, any health care facility with which an expert is affiliated, and the independent review organization arranging for the experts’ review shall not have any professional, familial, or financial affiliation with any of the following:
(a) The plan or any officer, director, or managerial employee of the plan;
(b) The plan member, the plan member’s physician, or the practice group of the plan member’s physician;
(c) The health care facility at which the recommended or requested therapy would be provided;
(d) The development or manufacture of the principal drug, device, procedure, or therapy involved in the recommended or requested therapy. However, experts affiliated with academic medical centers who provide health care services to members of the plan may serve as experts on the review panel. Further, experts with staff privileges at a health care facility that provides health care services to members of the plan, as well as experts who have a contractual relationship with the plan, but who were not involved with the plan’s denial of coverage for the therapy under review, may serve as experts on the review panel. These nonaffiliation provisions do not preclude a plan from paying for the experts’ review, as specified in division (C)(5) of this section.
(5) Plan members shall not be required to pay for any part of the cost of the review. The cost of the review shall be borne by the plan.
(6) The plan shall provide to the independent review organization arranging for the experts’ review a copy of those records in the plan’s possession that are relevant to the plan member’s medical condition and the review. The records shall be disclosed solely to the expert reviewers and shall be used solely for the purpose of this section. At the request of the expert reviewers, the plan or the physician requesting the therapy shall provide any additional information that the expert reviewers request to complete the review. An expert reviewer is not required to render an opinion if the reviewer has not received any requested information that the reviewer considers necessary to complete the review.
(7)(a) In the case of an expedited review, the independent review organization shall issue a written decision not later than seven days after the filing of the request for review. In all other cases, the independent review organization shall issue a written decision not later than thirty days after the filing of the request. The independent review organization shall send a copy of its decision to the plan and the plan member. If the plan member’s provider or the health care facility rendering health care services to the plan member requested the review, the independent review organization shall also send a copy of its decision to the plan member’s provider or the health care facility.
(b) In conducting the review, the experts on the panel shall take into account all of the following:
(i) Information submitted by the plan, the plan member, and the plan member’s physician, including the plan member’s medical records and the standards, criteria, and clinical rationale used by the plan to reach its coverage decision;
(ii) Findings, studies, research, and other relevant documents of government agencies and nationally recognized organizations;
(iii) Relevant findings in peer-reviewed medical or scientific literature and published opinions of nationally recognized medical experts;
(iv) Clinical guidelines adopted by relevant national medical societies;
(v) Safety, efficacy, appropriateness, and cost-effectiveness.
(8) Each expert on the panel shall provide the independent review organization with a professional opinion as to whether there is sufficient evidence to demonstrate that the recommended or requested therapy is likely to be more beneficial to the plan member than standard therapies.
(9) Each expert’s opinion shall be presented in written form and shall include the following information:
(a) A description of the plan member’s condition;
(b) A description of the indicators relevant to determining whether there is sufficient evidence to demonstrate that the recommended or requested therapy is more likely than not to be more beneficial to the plan member than standard therapies;
(c) A description and analysis of any relevant findings published in peer-reviewed medical or scientific literature or the published opinions of medical experts or specialty societies;
(d) A description of the plan member’s suitability to receive the recommended or requested therapy according to a treatment protocol in a clinical trial, if applicable.
(10) The independent review organization shall provide the plan with the opinions of the experts. The plan shall make the experts’ opinions available to the plan member and the plan member’s physician, upon request.
(11) The opinion of the majority of the experts on the panel, rendered pursuant to division (C)(8) of this section, is binding on the plan with respect to that plan member. If the opinions of the experts on the panel are evenly divided as to whether the therapy should be covered, the plan’s final decision shall be in favor of coverage. If less than a majority of the experts on the panel recommend coverage of the therapy, the plan may, in its discretion, cover the therapy. However, any coverage provided pursuant to division (C)(11) of this section is subject to the terms, limitations, and conditions of the plan.
(12) The plan shall have written policies describing the external review process.
(D) If a plan’s initial denial of coverage for a therapy recommended or requested pursuant to division (A)(3) of this section is based upon an external review of that therapy meeting the requirements of division (C) of this section, this section shall not be a basis for requiring a second external review of the recommended or requested therapy.
(E) At any time during the external review process, the plan may elect to cover the recommended or requested health care service and terminate the review. The plan shall notify the plan member and all other parties involved by mail or, with consent or approval of the plan member, by electronic means.
(F) The plan shall annually file a certificate with the superintendent of insurance certifying its compliance with the requirements of this section.
Amended by 128th General Assembly File No. 9, HB 1, § 101.01, eff. 10/16/2009.
3923.77 Establishing reasonable external, independent review process - public employee benefit plan.
(A) Each public employee benefit plan shall establish a reasonable external review process to examine the plan’s coverage decisions for plan members who meet all of the following criteria:
(1) The plan member has a terminal condition that, according to the current diagnosis of the plan member’s physician, has a high probability of causing death within two years.
(2) The plan member requests a review not later than one hundred eighty days after receipt by the plan member of notice from the plan of the adverse decision.
(3) The plan member’s physician certifies that the plan member has the condition described in division (A)(1) of this section and any of the following situations are applicable:
(a) Standard therapies have not been effective in improving the condition of the plan member.
(b) Standard therapies are not medically appropriate for the plan member.
(c) There is no standard therapy covered by the plan that is more beneficial than therapy described in division (A)(4) of this section.
(4) The plan member’s physician has recommended a drug, device, procedure, or other therapy that the physician certifies, in writing, is likely to be more beneficial to the plan member, in the physician’s opinion, than standard therapies, or the plan member has requested a therapy that has been found in a preponderance of peer-reviewed published studies to be associated with effective clinical outcomes for the same condition.
(5) The plan member has been denied coverage by the plan for a drug, device, procedure, or other therapy recommended or requested pursuant to division (A)(4) of this section, and has exhausted all internal appeals.
(6) The drug, device, procedure, or other therapy, for which coverage has been denied, would be a covered health care service except for the plan’s determination that the drug, device, procedure, or other therapy is experimental or investigational.
(B) A review shall be requested in writing, except that if the plan member’s physician determines that a therapy would be significantly less effective if not promptly initiated, the review may be requested orally or by electronic means. When an oral or electronic request for review is made, written confirmation of the request shall be submitted to the plan not later than five days after the oral or written request is submitted. For an expedited review, the plan member’s provider must certify that the requested or recommended therapy would be significantly less effective if not promptly initiated.
(C) The external review process established by a plan shall meet all of the following criteria:
(1) Except as provided in division (E) of this section, the process shall afford all plan members who meet the criteria set forth in division (A) of this section the opportunity to have the plan’s decision to deny coverage of the recommended or requested therapy reviewed under the process. Each eligible plan member shall be notified of that opportunity within thirty business days after the plan denies coverage.
(2) The review shall be conducted by an independent review organization assigned by the superintendent of insurance under section 3901.80 of the Revised Code. The independent review organization shall select a panel to conduct the review, which panel shall be composed of at least three physicians or other providers who, through clinical experience in the past three years, are experts in the treatment of the plan member’s medical condition and knowledgeable about the recommended or requested therapy. If the independent review organization retained by the plan is an academic medical center, the panel may include experts affiliated with or employed by the academic medical center.
In either of the following circumstances, an exception may be made to the requirement that the review be conducted by an expert panel composed of a minimum of three physicians or other providers:
(a) A review may be conducted by an expert panel composed of only two physicians or other providers if a plan member has consented in writing to a review by the smaller panel.
(b) A review may be conducted by a single expert physician or other provider if only the expert physician or other provider is available for the review.
(3) Neither the plan nor the plan member shall choose, or control the choice of, the physician or other provider experts.
(4) The selected experts, any health care facility with which an expert is affiliated, and the independent review organization arranging for the experts’ review shall not have any professional, familial, or financial affiliation with any of the following:
(a) The plan or any officer, director, or managerial employee of the plan;
(b) The plan member, the plan member’s physician, or the practice group of the plan member’s physician;
(c) The health care facility at which the recommended or requested therapy would be provided;
(d) The development or manufacture of the principal drug, device, procedure, or therapy involved in the recommended or requested therapy. However, experts affiliated with academic medical centers who provide health care services to members of the plan may serve as experts on the review panel. Further, experts with staff privileges at a health care facility that provides health care services to members of the plan, as well as experts who have a contractual relationship with the plan, but who were not involved with the plan’s denial of coverage for the therapy under review, may serve as experts on the review panel. These nonaffiliation provisions do not preclude a plan from paying for the experts’ review, as specified in division (C)(5) of this section.
(5) Plan members shall not be required to pay for any part of the cost of the review. The cost of the review shall be borne by the plan.
(6) The plan shall provide to the independent review organization arranging for the experts’ review a copy of those records in the plan’s possession that are relevant to the plan member’s medical condition and the review. The records shall be disclosed solely to the expert reviewers and shall be used solely for the purpose of this section. At the request of the expert reviewers, the plan or the physician requesting the therapy shall provide any additional information that the expert reviewers request to complete the review. An expert reviewer is not required to render an opinion if the reviewer has not received any requested information that the reviewer considers necessary to complete the review.
(7)(a) In the case of an expedited review, the independent review organization shall issue a written decision not later than seven days after the filing of the request for review. In all other cases, the independent review organization shall issue a written decision not later than thirty days after the filing of the request. The independent review organization shall send a copy of its decision to the plan and the plan member. If the plan member’s provider or the health care facility rendering health care services to the plan member requested the review, the independent review organization shall also send a copy of its decision to the plan member’s provider or the health care facility.
(b) In conducting the review, the experts on the panel shall take into account all of the following:
(i) Information submitted by the plan, the plan member, and the plan member’s physician, including the plan member’s medical records and the standards, criteria, and clinical rationale used by the plan to reach its coverage decision;
(ii) Findings, studies, research, and other relevant documents of government agencies and nationally recognized organizations;
(iii) Relevant findings in peer-reviewed medical or scientific literature and published opinions of nationally recognized medical experts;
(iv) Clinical guidelines adopted by relevant national medical societies;
(v) Safety, efficacy, appropriateness, and cost-effectiveness.
(8) Each expert on the panel shall provide the independent review organization with a professional opinion as to whether there is sufficient evidence to demonstrate that the recommended or requested therapy is likely to be more beneficial to the plan member than standard therapies.
(9) Each expert’s opinion shall be presented in written form and shall include the following information:
(a) A description of the plan member’s condition;
(b) A description of the indicators relevant to determining whether there is sufficient evidence to demonstrate that the recommended or requested therapy is more likely than not to be more beneficial to the plan member than standard therapies;
(c) A description and analysis of any relevant findings published in peer-reviewed medical or scientific literature or the published opinions of medical experts or specialty societies;
(d) A description of the plan member’s suitability to receive the recommended or requested therapy according to a treatment protocol in a clinical trial, if applicable.
(10) The independent review organization shall provide the plan with the opinions of the experts. The plan shall make the experts’ opinions available to the plan member and the plan member’s physician, upon request.
(11) The opinion of the majority of the experts on the panel, rendered pursuant to division (C)(8) of this section, is binding on the plan with respect to that plan member. If the opinions of the experts on the panel are evenly divided as to whether the therapy should be covered, the plan’s final decision shall be in favor of coverage. If less than a majority of the experts on the panel recommend coverage of the therapy, the plan may, in its discretion, cover the therapy. However, any coverage provided pursuant to division (C)(11) of this section is subject to the terms, limitations, and conditions of the plan.
(12) The plan shall have written policies describing the external review process.
(D) If a plan’s initial denial of coverage for a therapy recommended or requested pursuant to division (A)(3) of this section is based upon an external review of that therapy meeting the requirements of division (C) of this section, this section shall not be a basis for requiring a second external review of the recommended or requested therapy.
(E) At any time during the external review process, the plan may elect to cover the recommended or requested health care service and terminate the review. The plan shall notify the plan member and all other parties involved by mail or, with consent or approval of the plan member, by electronic means.
(F) The plan shall annually file a certificate with the superintendent of insurance certifying its compliance with the requirements of this section.
Amended by 128th General Assembly File No. 9, HB 1, § 101.01, eff. 10/16/2009.
3923.77 Establishing reasonable external, independent review process - public employee benefit plan.
(A) Each public employee benefit plan shall establish a reasonable external review process to examine the plan’s coverage decisions for plan members who meet all of the following criteria:
(1) The plan member has a terminal condition that, according to the current diagnosis of the plan member’s physician, has a high probability of causing death within two years.
(2) The plan member requests a review not later than one hundred eighty days after receipt by the plan member of notice from the plan of the adverse decision.
(3) The plan member’s physician certifies that the plan member has the condition described in division (A)(1) of this section and any of the following situations are applicable:
(a) Standard therapies have not been effective in improving the condition of the plan member.
(b) Standard therapies are not medically appropriate for the plan member.
(c) There is no standard therapy covered by the plan that is more beneficial than therapy described in division (A)(4) of this section.
(4) The plan member’s physician has recommended a drug, device, procedure, or other therapy that the physician certifies, in writing, is likely to be more beneficial to the plan member, in the physician’s opinion, than standard therapies, or the plan member has requested a therapy that has been found in a preponderance of peer-reviewed published studies to be associated with effective clinical outcomes for the same condition.
(5) The plan member has been denied coverage by the plan for a drug, device, procedure, or other therapy recommended or requested pursuant to division (A)(4) of this section, and has exhausted all internal appeals.
(6) The drug, device, procedure, or other therapy, for which coverage has been denied, would be a covered health care service except for the plan’s determination that the drug, device, procedure, or other therapy is experimental or investigational.
(B) A review shall be requested in writing, except that if the plan member’s physician determines that a therapy would be significantly less effective if not promptly initiated, the review may be requested orally or by electronic means. When an oral or electronic request for review is made, written confirmation of the request shall be submitted to the plan not later than five days after the oral or written request is submitted. For an expedited review, the plan member’s provider must certify that the requested or recommended therapy would be significantly less effective if not promptly initiated.
(C) The external review process established by a plan shall meet all of the following criteria:
(1) Except as provided in division (E) of this section, the process shall afford all plan members who meet the criteria set forth in division (A) of this section the opportunity to have the plan’s decision to deny coverage of the recommended or requested therapy reviewed under the process. Each eligible plan member shall be notified of that opportunity within thirty business days after the plan denies coverage.
(2) The review shall be conducted by an independent review organization assigned by the superintendent of insurance under section 3901.80 of the Revised Code. The independent review organization shall select a panel to conduct the review, which panel shall be composed of at least three physicians or other providers who, through clinical experience in the past three years, are experts in the treatment of the plan member’s medical condition and knowledgeable about the recommended or requested therapy. If the independent review organization retained by the plan is an academic medical center, the panel may include experts affiliated with or employed by the academic medical center.
In either of the following circumstances, an exception may be made to the requirement that the review be conducted by an expert panel composed of a minimum of three physicians or other providers:
(a) A review may be conducted by an expert panel composed of only two physicians or other providers if a plan member has consented in writing to a review by the smaller panel.
(b) A review may be conducted by a single expert physician or other provider if only the expert physician or other provider is available for the review.
(3) Neither the plan nor the plan member shall choose, or control the choice of, the physician or other provider experts.
(4) The selected experts, any health care facility with which an expert is affiliated, and the independent review organization arranging for the experts’ review shall not have any professional, familial, or financial affiliation with any of the following:
(a) The plan or any officer, director, or managerial employee of the plan;
(b) The plan member, the plan member’s physician, or the practice group of the plan member’s physician;
(c) The health care facility at which the recommended or requested therapy would be provided;
(d) The development or manufacture of the principal drug, device, procedure, or therapy involved in the recommended or requested therapy. However, experts affiliated with academic medical centers who provide health care services to members of the plan may serve as experts on the review panel. Further, experts with staff privileges at a health care facility that provides health care services to members of the plan, as well as experts who have a contractual relationship with the plan, but who were not involved with the plan’s denial of coverage for the therapy under review, may serve as experts on the review panel. These nonaffiliation provisions do not preclude a plan from paying for the experts’ review, as specified in division (C)(5) of this section.
(5) Plan members shall not be required to pay for any part of the cost of the review. The cost of the review shall be borne by the plan.
(6) The plan shall provide to the independent review organization arranging for the experts’ review a copy of those records in the plan’s possession that are relevant to the plan member’s medical condition and the review. The records shall be disclosed solely to the expert reviewers and shall be used solely for the purpose of this section. At the request of the expert reviewers, the plan or the physician requesting the therapy shall provide any additional information that the expert reviewers request to complete the review. An expert reviewer is not required to render an opinion if the reviewer has not received any requested information that the reviewer considers necessary to complete the review.
(7)(a) In the case of an expedited review, the independent review organization shall issue a written decision not later than seven days after the filing of the request for review. In all other cases, the independent review organization shall issue a written decision not later than thirty days after the filing of the request. The independent review organization shall send a copy of its decision to the plan and the plan member. If the plan member’s provider or the health care facility rendering health care services to the plan member requested the review, the independent review organization shall also send a copy of its decision to the plan member’s provider or the health care facility.
(b) In conducting the review, the experts on the panel shall take into account all of the following:
(i) Information submitted by the plan, the plan member, and the plan member’s physician, including the plan member’s medical records and the standards, criteria, and clinical rationale used by the plan to reach its coverage decision;
(ii) Findings, studies, research, and other relevant documents of government agencies and nationally recognized organizations;
(iii) Relevant findings in peer-reviewed medical or scientific literature and published opinions of nationally recognized medical experts;
(iv) Clinical guidelines adopted by relevant national medical societies;
(v) Safety, efficacy, appropriateness, and cost-effectiveness.
(8) Each expert on the panel shall provide the independent review organization with a professional opinion as to whether there is sufficient evidence to demonstrate that the recommended or requested therapy is likely to be more beneficial to the plan member than standard therapies.
(9) Each expert’s opinion shall be presented in written form and shall include the following information:
(a) A description of the plan member’s condition;
(b) A description of the indicators relevant to determining whether there is sufficient evidence to demonstrate that the recommended or requested therapy is more likely than not to be more beneficial to the plan member than standard therapies;
(c) A description and analysis of any relevant findings published in peer-reviewed medical or scientific literature or the published opinions of medical experts or specialty societies;
(d) A description of the plan member’s suitability to receive the recommended or requested therapy according to a treatment protocol in a clinical trial, if applicable.
(10) The independent review organization shall provide the plan with the opinions of the experts. The plan shall make the experts’ opinions available to the plan member and the plan member’s physician, upon request.
(11) The opinion of the majority of the experts on the panel, rendered pursuant to division (C)(8) of this section, is binding on the plan with respect to that plan member. If the opinions of the experts on the panel are evenly divided as to whether the therapy should be covered, the plan’s final decision shall be in favor of coverage. If less than a majority of the experts on the panel recommend coverage of the therapy, the plan may, in its discretion, cover the therapy. However, any coverage provided pursuant to division (C)(11) of this section is subject to the terms, limitations, and conditions of the plan.
(12) The plan shall have written policies describing the external review process.
(D) If a plan’s initial denial of coverage for a therapy recommended or requested pursuant to division (A)(3) of this section is based upon an external review of that therapy meeting the requirements of division (C) of this section, this section shall not be a basis for requiring a second external review of the recommended or requested therapy.
(E) At any time during the external review process, the plan may elect to cover the recommended or requested health care service and terminate the review. The plan shall notify the plan member and all other parties involved by mail or, with consent or approval of the plan member, by electronic means.
(F) The plan shall annually file a certificate with the superintendent of insurance certifying its compliance with the requirements of this section.
Amended by 128th General Assembly File No. 9, HB 1, § 101.01, eff. 10/16/2009.
