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it is Investigational. A health intervention not meeting all of the following criteria, is, in the <br />Company's judgment, Investigational: <br />Q The Scientific Evidence must permit conclusions concerning the effect of the <br />Health Intervention on health outcomes, which include the disease process, <br />Injury or Illness, length of life, ability to function and quality of life. <br />The health intervention must improve net health outcome. <br />• The Scientific Evidence must show that the health intervention is as beneficial as <br />any established alternatives. <br />• The improvement must be attainable outside the laboratory or clinical research <br />setting. <br />For purposes of this definition, Scientific Evidence means scientific studies published in <br />or accepted for publication by medical journals that meet nationally recognized <br />requirements for scientific manuscripts and that submit most of their published articles for <br />review by experts who are not part of the editorial staff; or findings, studies or research <br />conducted by or under the auspices of federal government agencies and nationally <br />recognized federal research institutes. However, Scientific Evidence shall not include <br />published peer-reviewed literature sponsored to a significant extent by a pharmaceutical <br />manufacturing company or medical device manufacturer or a single study without other <br />supportable studies. <br />II. PROVISION OF MEDICAL SERVICES <br />2.1 MEDICALLY NECESSARY SERVICES — Medical Group will provide Medically <br />Necessary Services to Members in accordance with the terms of this Agreement. <br />Company will only bear financial responsibility for Medically Necessary, Covered <br />Services furnished to Members by Medical Group. Company will not make retroactive <br />denials of Covered Services that were pre -certified or concurrently certified as medically <br />necessary unless the certification was based upon a material misrepresentation by <br />Medical Group. <br />2.2 COVERED SERVICES — Company will define the Covered Services for the Health Plans <br />for which Medical Group has agreed to provide services. <br />2.3 STANDARDS OF CARE — The Medical Group shall provide services to Members in <br />accordance with generally accepted professional standards of care and medical and <br />billing practices in the community. Medical Group agrees to furnish Covered Services to <br />Members without regard to the Member's enrollment in the Health Plan as a private <br />purchaser or as a participant in publicly funded programs. <br />2.4 RELATIONSHIP WITH MEMBERS — Company will not be liable for nor will it exercise <br />control or direction over the methods or professional judgments relied upon by Medical <br />Group and Medical Group's Providers, employees or representatives in providing <br />services pursuant to this Agreement. Medical Group will be solely responsible for <br />supervising and controlling Medical Group's employees to assure that such services are <br />provided in a manner that complies with generally accepted standards of care. Medical <br />Group Provider will be responsible for clinical decisions regarding the medical care and <br />treatment of Members. Nothing in this Agreement limits Medical Group Provider's right to <br />communicate freely with Members, including the right to inform Members that Medical <br />Group Provider believes services are appropriate or necessary, even if Company has <br />determined the services are not Covered Services. <br />2.5 NONDISCRIMINATION - Medical Group will provide the Covered Services contemplated <br />herein without regard to the race, age, sex, religion, creed, color, national origin or <br />ancestry of any Member. During the term of this Agreement, Medical Group will not <br />unlawfully discriminate against any employee or applicant for employment because of <br />race, religion, color, national origin, ancestry, physical handicap, health status, marital <br />Asuris MGA Agreement (Rev. 05/2017) Al8816854AA Page 4 of 20 <br />