1751.85 Reasonable external, independent review process.
1751.85 Reasonable external, independent review process.
(A) Each health insuring corporation shall establish a reasonable external, independent review process to examine the health insuring corporation’s coverage decisions for enrollees who meet all of the following criteria:
(1) The enrollee has a terminal condition that, according to the current diagnosis of the enrollee’s physician, has a high probability of causing death within two years.
(2) The enrollee requests a review not later than one hundred eighty days after receipt by the enrollee of notice of the result of an internal review under section 1751.83 of the Revised Code.
(3) The enrollee’s physician certifies that the enrollee 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 enrollee;
(b) Standard therapies are not medically appropriate for the enrollee;
(c) There is no standard therapy covered by the health insuring corporation that is more beneficial than therapy described in division (A)(4) of this section.
(4) The enrollee’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 enrollee, in the physician’s opinion, than standard therapies, or, the enrollee 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 enrollee has been denied coverage by the health insuring corporation for a drug, device, procedure, or other therapy recommended or requested pursuant to division (A)(4) of this section, and has exhausted the health insuring corporation’s internal review process established pursuant to section 1751.83 of the Revised Code.
(6) The drug, device, procedure, or other therapy, for which coverage has been denied would be a covered health care service except for the health insuring corporation’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 enrollee’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 health insuring corporation not later than five days after the oral or written request is submitted.
(C) The external, independent review process established by a health insuring corporation shall meet all of the following criteria:
(1) Except as provided in division (E) of this section, the process shall afford all enrollees who meet the criteria set forth in division (A) of this section the opportunity to have the health insuring corporation’s decision to deny coverage of the recommended or requested therapy reviewed under the process.
(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 enrollee’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 enrollee 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 one expert physician or other provider is available for the review.
(3) Neither the health insuring corporation nor the enrollee 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 health insuring corporation or any officer, director, or managerial employee of the health insuring corporation;
(b) The enrollee, the enrollee’s physician, or the practice group of the enrollee’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 enrollees of the health insuring corporation may serve as experts on the review panel. Further, experts with staff privileges at a health care facility that provides health care services to enrollees of the health insuring corporation, as well as experts who are participating providers, but who were not involved with the health insuring corporation’s denial of coverage for the therapy under review, may serve as experts on the review panel. These nonaffiliation provisions do not preclude a health insuring corporation from paying for the experts’ review, as specified in division (C)(5) of this section.
(5) Enrollees 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 health insuring corporation.
(6) The health insuring corporation shall provide to the independent review organization arranging for the experts’ review a copy of those records in the health insuring corporation’s possession that are relevant to the enrollee’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 health insuring corporation or the physician recommending 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) The opinions of the experts on the panel shall be rendered within thirty days after the enrollee’s request for review. If the enrollee’s physician determines that a therapy would be significantly less effective if not promptly initiated, the opinions shall be rendered within seven days after the enrollee’s request for review.
(b) In conducting the review, the experts on the panel shall take into account all of the following:
(i) Information submitted by the health insuring corporation, the enrollee, and the enrollee’s physician, including the enrollee’s medical records and the standards, criteria, and clinical rationale used by the health insuring corporation 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 enrollee 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 enrollee’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 enrollee 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 enrollee’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 health insuring corporation with the opinions of the experts. The health insuring corporation shall make the experts’ opinions available to the enrollee and the enrollee’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 health insuring corporation with respect to that enrollee. If the opinions of the experts on the panel are evenly divided as to whether the therapy should be covered, then the health insuring corporation’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 health insuring corporation 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 enrollee’s contract with the health insuring corporation.
(12) The health insuring corporation shall have written policies describing the external, independent review process.
(D) At any time during the external, independent review process, the health insuring corporation may elect to cover the recommended or requested health care service and terminate the review. The health insuring corporation shall notify the enrollee and all other parties involved by mail or, with the consent or approval of the enrollee, by electronic means.
(E) If a health insuring corporation’s initial denial of coverage for a therapy recommended or requested pursuant to division (A)(4) 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.
(F) The health insuring corporation 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.
Effective Date: 05-01-2000