(A) Each insurer shall establish a reasonable external, independent review process to examine the insurer’s coverage decisions for insureds who meet all of the following criteria:
(1) The insured has a terminal condition that, according to the current diagnosis of the insured’s physician, has a high probability of causing death within two years.
(2) The insured requests a review not later than one hundred eighty days after receipt by the insured of notice from the insurer of the adverse decision.
(3) The insured’s physician certifies that the insured 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 insured.
(b) Standard therapies are not medically appropriate for the insured.
(c) There is no standard therapy covered by the insurer that is more beneficial than therapy described in division (A)(4) of this section.
(4) The insured’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 insured, in the physician’s opinion, than standard therapies, or the insured 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 insured has been denied coverage by the insurer for a drug, device, procedure, or other therapy recommended or requested pursuant to division (A)(4) of this section, and has exhausted the insurer’s internal review process.
(6) The drug, device, procedure, or other therapy, for which coverage has been denied, would be a covered health care service except for the insurer’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 insured’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 insurer not later than five days after the oral or written request is submitted.
(C) The external, independent review process established by an insurer shall meet all of the following criteria:
(1) Except as provided in division (E) of this section, the process shall afford all insureds who meet the criteria set forth in division (A) of this section the opportunity to have the insurer’s decision to deny coverage of the recommended or requested therapy reviewed under the process. Each eligible insured shall be notified of that opportunity within thirty business days after the insurer 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 insured’s medical condition and knowledgeable about the recommended or requested therapy.
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 an insured 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 insurer nor the insured 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 insurer or any officer, director, or managerial employee of the insurer;
(b) The insured, the insured’s physician, or the practice group of the insured’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 insureds of the insurer may serve as experts on the review panel. Further, experts with staff privileges at a health care facility that provides health care services to insureds of the insurer, as well as experts who have a contractual relationship with the insurer, but who were not involved with the insurer’s denial of coverage for the therapy under review, may serve as experts on the review panel. These nonaffiliation provisions do not preclude an insurer from paying for the experts’ review, as specified in division (C)(5) of this section.
(5) Insureds 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 insurer.
(6) The insurer shall provide to the independent review organization arranging for the experts’ review a copy of those records in the insurer’s possession that are relevant to the insured’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 insurer 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 insurer and the insured. If the insured’s provider or the health care facility rendering health care services to the insured requested the review, the independent review organization shall also send a copy of its decision to the insured’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 insurer, the insured, and the insured’s physician, including the insured’s medical records and the standards, criteria, and clinical rationale used by the insurer 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 insured 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 insured’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 insured 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 insured’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 insurer with the opinions of the experts. The insurer shall make the experts’ opinions available to the insured and the insured’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 insurer with respect to that insured. If the opinions of the experts on the panel are evenly divided as to whether the therapy should be covered, the insurer’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 insurer 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 insured’s policy or certificate with the insurer.
(12) The insurer shall have written policies describing the external, independent review process.
(D) If an insurer’s initial denial of coverage for a therapy recommended or requested pursuant to division (A)(3) of this section is based upon an external, independent 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, independent review of the recommended or requested therapy.
(E) At any time during the external, independent review process, the insurer may elect to cover the recommended or requested health care service and terminate the review. The insurer shall notify the insured and all other parties involved by mail or, with consent or approval of the insured, by electronic means.
(F) The insurer 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.
(A) Each insurer shall establish a reasonable external, independent review process to examine the insurer’s coverage decisions for insureds who meet all of the following criteria:
(1) The insured has a terminal condition that, according to the current diagnosis of the insured’s physician, has a high probability of causing death within two years.
(2) The insured requests a review not later than one hundred eighty days after receipt by the insured of notice from the insurer of the adverse decision.
(3) The insured’s physician certifies that the insured 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 insured.
(b) Standard therapies are not medically appropriate for the insured.
(c) There is no standard therapy covered by the insurer that is more beneficial than therapy described in division (A)(4) of this section.
(4) The insured’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 insured, in the physician’s opinion, than standard therapies, or the insured 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 insured has been denied coverage by the insurer for a drug, device, procedure, or other therapy recommended or requested pursuant to division (A)(4) of this section, and has exhausted the insurer’s internal review process.
(6) The drug, device, procedure, or other therapy, for which coverage has been denied, would be a covered health care service except for the insurer’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 insured’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 insurer not later than five days after the oral or written request is submitted.
(C) The external, independent review process established by an insurer shall meet all of the following criteria:
(1) Except as provided in division (E) of this section, the process shall afford all insureds who meet the criteria set forth in division (A) of this section the opportunity to have the insurer’s decision to deny coverage of the recommended or requested therapy reviewed under the process. Each eligible insured shall be notified of that opportunity within thirty business days after the insurer 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 insured’s medical condition and knowledgeable about the recommended or requested therapy.
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 an insured 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 insurer nor the insured 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 insurer or any officer, director, or managerial employee of the insurer;
(b) The insured, the insured’s physician, or the practice group of the insured’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 insureds of the insurer may serve as experts on the review panel. Further, experts with staff privileges at a health care facility that provides health care services to insureds of the insurer, as well as experts who have a contractual relationship with the insurer, but who were not involved with the insurer’s denial of coverage for the therapy under review, may serve as experts on the review panel. These nonaffiliation provisions do not preclude an insurer from paying for the experts’ review, as specified in division (C)(5) of this section.
(5) Insureds 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 insurer.
(6) The insurer shall provide to the independent review organization arranging for the experts’ review a copy of those records in the insurer’s possession that are relevant to the insured’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 insurer 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 insurer and the insured. If the insured’s provider or the health care facility rendering health care services to the insured requested the review, the independent review organization shall also send a copy of its decision to the insured’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 insurer, the insured, and the insured’s physician, including the insured’s medical records and the standards, criteria, and clinical rationale used by the insurer 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 insured 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 insured’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 insured 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 insured’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 insurer with the opinions of the experts. The insurer shall make the experts’ opinions available to the insured and the insured’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 insurer with respect to that insured. If the opinions of the experts on the panel are evenly divided as to whether the therapy should be covered, the insurer’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 insurer 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 insured’s policy or certificate with the insurer.
(12) The insurer shall have written policies describing the external, independent review process.
(D) If an insurer’s initial denial of coverage for a therapy recommended or requested pursuant to division (A)(3) of this section is based upon an external, independent 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, independent review of the recommended or requested therapy.
(E) At any time during the external, independent review process, the insurer may elect to cover the recommended or requested health care service and terminate the review. The insurer shall notify the insured and all other parties involved by mail or, with consent or approval of the insured, by electronic means.
(F) The insurer 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.
(A) Each insurer shall establish a reasonable external, independent review process to examine the insurer’s coverage decisions for insureds who meet all of the following criteria:
(1) The insured has a terminal condition that, according to the current diagnosis of the insured’s physician, has a high probability of causing death within two years.
(2) The insured requests a review not later than one hundred eighty days after receipt by the insured of notice from the insurer of the adverse decision.
(3) The insured’s physician certifies that the insured 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 insured.
(b) Standard therapies are not medically appropriate for the insured.
(c) There is no standard therapy covered by the insurer that is more beneficial than therapy described in division (A)(4) of this section.
(4) The insured’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 insured, in the physician’s opinion, than standard therapies, or the insured 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 insured has been denied coverage by the insurer for a drug, device, procedure, or other therapy recommended or requested pursuant to division (A)(4) of this section, and has exhausted the insurer’s internal review process.
(6) The drug, device, procedure, or other therapy, for which coverage has been denied, would be a covered health care service except for the insurer’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 insured’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 insurer not later than five days after the oral or written request is submitted.
(C) The external, independent review process established by an insurer shall meet all of the following criteria:
(1) Except as provided in division (E) of this section, the process shall afford all insureds who meet the criteria set forth in division (A) of this section the opportunity to have the insurer’s decision to deny coverage of the recommended or requested therapy reviewed under the process. Each eligible insured shall be notified of that opportunity within thirty business days after the insurer 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 insured’s medical condition and knowledgeable about the recommended or requested therapy.
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 an insured 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 insurer nor the insured 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 insurer or any officer, director, or managerial employee of the insurer;
(b) The insured, the insured’s physician, or the practice group of the insured’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 insureds of the insurer may serve as experts on the review panel. Further, experts with staff privileges at a health care facility that provides health care services to insureds of the insurer, as well as experts who have a contractual relationship with the insurer, but who were not involved with the insurer’s denial of coverage for the therapy under review, may serve as experts on the review panel. These nonaffiliation provisions do not preclude an insurer from paying for the experts’ review, as specified in division (C)(5) of this section.
(5) Insureds 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 insurer.
(6) The insurer shall provide to the independent review organization arranging for the experts’ review a copy of those records in the insurer’s possession that are relevant to the insured’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 insurer 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 insurer and the insured. If the insured’s provider or the health care facility rendering health care services to the insured requested the review, the independent review organization shall also send a copy of its decision to the insured’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 insurer, the insured, and the insured’s physician, including the insured’s medical records and the standards, criteria, and clinical rationale used by the insurer 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 insured 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 insured’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 insured 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 insured’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 insurer with the opinions of the experts. The insurer shall make the experts’ opinions available to the insured and the insured’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 insurer with respect to that insured. If the opinions of the experts on the panel are evenly divided as to whether the therapy should be covered, the insurer’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 insurer 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 insured’s policy or certificate with the insurer.
(12) The insurer shall have written policies describing the external, independent review process.
(D) If an insurer’s initial denial of coverage for a therapy recommended or requested pursuant to division (A)(3) of this section is based upon an external, independent 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, independent review of the recommended or requested therapy.
(E) At any time during the external, independent review process, the insurer may elect to cover the recommended or requested health care service and terminate the review. The insurer shall notify the insured and all other parties involved by mail or, with consent or approval of the insured, by electronic means.
(F) The insurer 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.
