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The 100 Most Important Things To Know About Your Character (revised)

By Irene Diaz,2014-02-06 16:21
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The 100 Most Important Things To Know About Your Character (revised)

Product Regulation Ohio Department of Insurance Life & Health, Managed Care rdJohn R. Kasich Governor 50 W. Town St., 3 Fl Mary Taylor Lt. Governor/Director Suite 300 Columbus, OH 43215 (614) 644-2661 Application for Accreditation as an IRO for Fax # (614) 728-5238 Entities with National Accreditation www.insurance.ohio.gov

    Application for accreditation as an Independent Review Organization for Entities Accredited by a National

    Organization/Certification of Compliance with Ohio Specific Requirements

    To be submitted along with proof of current accreditation by a national organization that accredits

    independent review organizations. Proof shall include a certificate or letter of accreditation.

Legal Name of Applicant Federal Tax Identification Number Type of Entity: Corporation Partner Association Limited Liability Company Other Contact Person Name Phone Number Title ( ) Business Address Street (do not use P.O. Box) City State Zip Mailing Address Street (if different from business address) City State Zip Phone Number Fax Number Email Address State of Incorporation ( ) ( ) List all other states in which Applicant is approved to conduct external reviews. Identify all accreditations held by the Applicant. Has the Applicant ever been refused approval or accreditation to perform independent reviews? Yes No If yes, please explain. Has the Applicant ever lost approval or accreditation to perform independent reviews? Yes No If yes, please explain.

     1. Provide a chart showing the internal structure of the Applicant’s management and administrative staff. 2. Provide a list and brief description of all contractual arrangements between the Applicant, its parent, or any affiliates or subsidiaries. 3. Provide a list and brief description of all contractual arrangements that relate to the Applicant’s operations as an independent review organization. Note: Independent review organizations cannot subcontract services performed on behalf of Ohio Residents to another entity. 4. Provide an organizational chart of the holding company system that includes all of the information listed below for each entity that controls [as defined in Ohio Revised Code Section 3901.32(B)] or is controlled by the Applicant and all affiliates: a. The full legal name of the corporation or organization, b. Its state of incorporation or organization, c. A description of the goods and services it produces or provides, d. The nature and extent of the affiliation or control. Note: The holding company system includes any and all affiliates of the Applicant. 5. Include a list of any currently outstanding loans between the Applicant and any affiliates.

     Accredited by the National Association of Insurance Commissioners (NAIC) INS5035 (Rev. 01/2011) Page 1 of 5

    Ohio Department of Insurance Application for Accreditation as an IRO for Entities with National Accreditation

     1. Provide a copy, certified by the Secretary of State, of the Applicant’s Articles of Incorporation or Articles of Organization and all amendments to the documents. 2. Provide a copy, certified by a company officer, of the Applicant’s bylaws and all amendments. 3. Provide a certificate of good standing from your state of incorporation (corporations only). 4. Is the Applicant a publicly held entity? Yes No 5. Are there any stockholders or owners of more than 5% of any stock or options? Yes No If yes, give the name, address, percent of ownership, and Federal Tax Identification Number of each stockholder or owner of more than 5% of any stock or options.

     1. Is the Applicant a general partnership or limited partnership? 2. Provide a complete list of all partners, including full name, address, percent of ownership and Federal Tax Identification Number. 3. Provide a true and complete copy of your organizational documents including whatever is required by the state of domicile, the organization’s partnership agreement, and all amendments to the documents.

     Provide a certified copy of organizational documents appropriate to the Applicant. The organizational documents must include: any documents the state of domicile requires to be filed before the entity is authorized to operate in said state; the organization’s bylaws; and all amendments to the documents.

     Provide a listing giving the amount of bond or note for any holder of bonds or notes of the Applicant that exceeds $100,000 and for entities and individuals, their name, address, and Federal Tax Identification Number.

     1. Include the name and a complete biographical affidavit and release for each director or trustee, and officer of the Applicant, using the Department’s forms. 2. Include the name and a complete biographical affidavit and release for each similar person of any entity that owns or controls more than 5% of the Applicant. 3. In addition to the name and complete biographical affidavit and release, include for each individual a description of any professional, familial, or financial affiliation the named individual has with each of the following: a. A health insuring corporation or health maintenance organization, b. An insurer, c. A public employee benefit plan, d. A third party payor, e. A health care provider, f. A group representing any of the entities listed in items (a) through (e), g. Anyone employed by the Ohio Department of Insurance.

     Is the Applicant an entity which is domiciled in the state of Ohio? Yes No If yes, provide a certified copy of the Agent for Service of Process form as filed with the Ohio Secretary of State’s Office. If no, the Applicant must apply with the Ohio Secretary of State’s Office to conduct business in Ohio as a foreign entity. Please provide a certified copy of the Applicant’s license to do business in Ohio and a copy of the Applicant’s appointment of an Agent for Service of Process.

     Provide a statement of the percentage of the Applicant’s revenues which are anticipated to be to be derived from reviews conducted as an independent review organization and illustrate the method used to determine this amount.

     Accredited by the National Association of Insurance Commissioners (NAIC) INS5035 (Rev. 01/2011) Page 2 of 5

    Ohio Department of Insurance Application for Accreditation as an IRO for Entities with National Accreditation

     I, acting on behalf of (Applicant), being duly sworn, state that I have read and understood the foregoing application and attachments and that the answers are true and correct and further that I am familiar with the insurance laws of the state of Ohio and the rules of the Ohio Department of Insurance.

     1. An independent review organization shall issue a written decision not later than seven days after the filing of the request for review of all expedited reviews. For other cases the independent review organization shall issue a written decision not later than 30 days after the filing of the request. The independent review organization shall send a copy of its decision to the health insuring corporation, insurer or public employee benefit plan, and the enrollee, insured or plan member. If the provider or health care facility requested the review the independent review organization shall also send a copy of the review to that provider or health care facility. Requirements for External Reviews Conducted for Enrollees, Insureds or Plan Members whose Services were Determined to be not Medically Necessary 1. In making a decision, an independent review organization conducting a review shall take into account all of the following: a. Information submitted by the health insuring corporation, insurer or public employee benefit plan, the enrollee, insured or plan member, the provider, and the health care facility rendering the health care service, including the following: i. The enrollee’s, insured’s or plan member’s medical records; ii. The standards, criteria, and clinical rationale used by the health insuring corporation, insurer or public employee benefit plan to make its decision. b. Findings, studies, research, and other relevant documents of government agencies and nationally recognized organizations, including the National Institutes of Health or any board recognized by the National Institutes of Health, the National Cancer Institute, the National Academy of Sciences, the United States Food and Drug Administration, the Centers for Medicaid and Medicare Services of the United States Department of Health and Human Services and the Agency for Health Care Policy and Research. c. Relevant findings in peer-reviewed medical or scientific literature, published opinions of nationally recognized medical experts, and clinical guidelines adopted by relevant national medical societies. 2. The independent review organization shall base its decision on the information submitted. In making its decision, the independent review organization shall consider safety, efficacy, appropriateness, and cost-effectiveness. 3. The independent review organization shall include a description of the enrollee’s, insured’s or plan member’s condition and the principal reasons for the decision and an explanation of the clinical rationale for the decision. Requirements for External Reviews Conducted for Enrollees, Insureds or Plan Members with Terminal Conditions whose Services were Determined to be Experimental 1. Enrollees, insureds or plan members who meet the following criteria are entitled to an external review: a. The enrollee, insured or plan member has a terminal condition that according to the current diagnosis of the enrollee’s, insured’s or plan member’s physician, has a high probability of causing death within two years. b. The enrollee’s, insured’s or plan member’s physician certifies that the enrollee, insured or plan member has the condition described in this section and that any of the following situations are applicable: i. Standard therapies have not been effective in improving the condition of the enrollee, insured or plan member. ii. Standard therapies are not medically appropriate for the enrollee, insured or plan member. iii. There is no standard therapy covered by the health insuring corporation, insurer or public employee benefit plan that is more beneficial than therapy described in this section. c. The enrollee’s, insured’s or 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 enrollee, insured or plan member, in the physicians opinion, than standard therapies, or the enrollee, insured or 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 of the same condition. d. The enrollee, insured or plan member has been denied coverage by the health insuring corporation, insurer or public employee benefit plan for a drug, device, procedure, or other therapy recommended or requested pursuant to this division of this section and has exhausted the health insuring corporation’s, insurer’s or public employee benefit plan’s internal review process. e. 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, insurer’s or public employee benefit plan’s determination that the drug, device, procedure or other therapy is experimental or investigational. 2. The independent review organization shall select a panel to conduct the review. This 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, insured’s or plan member’s medical condition and knowledgeable about the recommended or requested therapy. 3. 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, insured or 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.

     Accredited by the National Association of Insurance Commissioners (NAIC) INS5035 (Rev. 01/2011) Page 3 of 5

Ohio Department of Insurance Application for Accreditation as an IRO for Entities with National Accreditation

4. In conducting the review, the experts on the panel shall take into account all of the following: a. Information submitted by the health insuring corporation, insurer or public employee benefit plan, the enrollee, insured or plan member and the physician, including the enrollee’s, insured’s or plan member’s medical records and the standards, criteria and clinical rational used by the health insuring corporation, insurer or public employee benefit plan to reach its coverage decision. b. Findings, studies, research, and other relevant documents of government agencies and nationally recognized organizations. c. Relevant findings in peer-reviewed medical or scientific literature and published opinions of nationally recognized medical experts. d. Clinical guidelines adopted by the relevant national medical societies. e. Safety, efficacy, appropriateness, and cost effectiveness. 5. 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, insured or plan member than standard therapies. 6. Each expert’s opinion shall be presented in written form and shall include the following information: a. A description of the enrollee’s, insured’s or 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 enrollee, insured or 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 enrollee’s, insured’s or plan member’s suitability to receive the recommended or requested therapy according to a treatment protocol in a clinical trial, if applicable. 7. The independent review organization shall provide the health insuring corporation, insurer or public employee benefit plan with the opinions of the experts. The health insuring corporation, insurer or public employee benefit plan shall make the experts’ opinions available to the enrollee, insured or plan member and the enrollee’s, insured’s or plan member’s physician, upon request.

Accredited by the National Association of Insurance Commissioners (NAIC) INS5035 (Rev. 01/2011) Page 4 of 5

    Ohio Department of Insurance Application for Accreditation as an IRO for Entities with National Accreditation

     I, acting on behalf of Applicant, certify that Applicant has received accreditation by to conduct independent external reviews. I also state that I have read and understand the following requirements for conducting external reviews for Ohio residents. I understand that these requirements may differ from those of the body that provided the accreditation for external reviews. I also certify that Applicant will adhere to these Ohio requirements when they differ from those of the accrediting body. However, in cases related to timing of reviews, Applicant may comply with the requirements of the accrediting body when those time periods are more stringent than the requirements in Ohio. I further certify that all of the following is true: ; All reviewers currently hold unrestricted licenses and are in good standing. ; No clinical peers, as defined in the Ohio Revised Code Section 1751.77(F) to be used as reviewers have ever been disciplined or sanctioned by a hospital or government entity based upon the quality of care provided. ; For physicians, all clinical peers are certified by a nationally recognized medical specialty board in the area that is the subject of their respective reviews. ; All reviewers performing reviews on behalf of Ohio enrollees, insureds, and plan members can complete the review process within the period prescribed by Ohio law. ; The Applicant is not operated by a national, state or local trade association of health benefit plans or health care providers. ; The Applicant agrees not to accept any particular case in the event of conflict of interest. The Applicant as an independent review organization will comply with the conflict of interest requirements of Ohio Administrative Code Section 3901-8-04(H). ; All clinical peers conducting external reviews are outside the employment of the Applicant. ; No health insuring corporation, insurer, or public employee benefit plan or enrollee, insured, or plan member shall choose or control the choice of clinical peers. ; The Applicant will comply with its credentialing process. ; The Applicant will comply with its procedures and Ohio law on confidentiality of medical records and patient identification. ; The Applicant agrees to use only the services of clinical peers with expertise in treating and clinical experience in the past three years with the service recommended or requested. ; The Applicant agrees not to subcontract the performance of its duties to any other entity. I avow that I have fully and truthfully completed this form to the best of my knowledge, information and belief. I further avow that I have the authority and capacity to execute this certification on behalf of the Applicant. I acknowledge that any fees associated with any external reviews pursuant to the Ohio Revised Code are the sole responsibility of the health insuring corporation, insurer, or public employee benefit plan whose medical decision is being reviewed, and I have no recourse against the Department of Insurance or the State of Ohio to the extent that any health insuring corporation, insurer or public employee benefit plan fails to pay any medical reviewer fees. I acknowledge that the Superintendent of Insurance has the sole discretion to add or remove the name of any independent review organization from the list of accredited independent review organizations, and the Superintendent’s decision to not accredit any organization or to remove any organization’s accreditation is not subject to administrative appeal or judicial review under Ohio Revised Code Chapter 119. I hereby waive any and all rights to contest the Superintendent’s decision to add, not add, remove or not remove any organization from the list.

     Applicant

     Signature

     Print or type full legal name

     Title

     State of

     County of

     Before me, , a notary public in and for the State of

     on this day personally appeared , known to me and acknowledged to me that (s)he executed the same for the purpose and consideration therein expressed, in the capacity therein stated.

     . Given under this hand and seal of office this day of , 20 Affix Notary Seal Here Notary Public, State of

     Accredited by the National Association of Insurance Commissioners (NAIC) INS5035 (Rev. 01/2011) Page 5 of 5

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