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    Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Academic Medical Centers

    Academic Medical Centers – Current as of March 2021

    Stark
    Stark exception related to both ownership/investment and compensation for services provided by an academic medical center 42 CFR 411.355(e)

    Anti-Kickback
    [No comparable safe harbor]

    The referring physician

    (a) is a bona fide employee of a component of the academic medical center on a full-time or substantial part-time basis. (A "component'' oaf an academic medical center means an affiliated medical school, faculty practice plan, hospital, teaching facility, institution of higher education, departmental professional corporation, or nonprofit support organization whose primary purpose is supporting the teaching mission of the academic medical center. The components need not be separate legal entities);

    (b) is licensed to practice medicine in the State(s) in which he or she practices medicine;

    (c) has a bona fide faculty appointment at the affiliated medical school or at one or more of the educational programs at the accredited academic hospital; and

    (d) provides either substantial academic services or substantial clinical teaching services (or a combination of academic services and clinical teaching services) for which the faculty member receives compensation as part of his or her employment relationship with the academic medical center. Parties should use a reasonable and consistent method for calculating a physician's academic services and clinical teaching services. A physician will be deemed to meet this requirement if he or she spends at least 20 percent of his or her professional time or 8 hours per week providing academic services or clinical teaching services (or a combination of academic services or clinical teaching services). A physician who does not spend at least 20 percent of his or her professional time or 8 hours per week providing academic services or clinical teaching services (or a combination of academic services or clinical teaching services) is not precluded from qualifying.

     

    The total compensation paid by all academic medical center components to the referring physician is set in advance and, in the aggregate, does not exceed fair market value for the services provided, and is not determined in any manner that takes into account the volume or value of referrals or other business generated by the referring physician within the academic medical center.

     
    If any compensation paid to the referring physician is conditioned on the physician’s referrals to a particular provider, practitioner, or supplier, the arrangement must also meet the following requirements (a) the compensation or formula for determining the compensation is set in advance for the duration of the arrangement (changes to the compensation or formula must be prospective); (b) the compensation must be consistent with the fair market value of the physician’s services, (c) the referral requirement must be set out in writing and signed by the parties, (d) the requirement to make referrals to a particular provider does not apply if the patient expresses a preference for a different provider, the patient’s insurer determines the provider, or the referral is not in the patient’s best medical interest in the physician’s judgment, (e) the required referrals relate solely to the physician’s scope of services covered by the employment, personal service, or managed care arrangement, and (f) neither the existence of the compensation arrangement nor the amount of compensation can be contingent on the number or value of the physician’s referrals to a particular provider, practitioner, or supplier, but the referral requirement may require the physician to refer an established percentage or ratio of the physician’s referrals to a particular provider, practitioner, or supplier.   

    All transfers of money between components of the academic medical center must directly or indirectly support the missions of teaching, indigent care, research, or community service.

     

    The relationship of the components of the academic medical center must be set forth in written agreement(s) or other written document(s) that have been adopted by the governing body of each component. If the academic medical center is one legal entity, this requirement will be satisfied if transfers of funds between components of the academic medical center are reflected in the routine financial reports covering the components.

     

    All money paid to a referring physician for research must be used solely to support bona fide research or teaching and must be consistent with the terms and conditions of the grant.

     

    The "academic medical center" consists of: (a) an accredited medical school (including a university, when appropriate) or an accredited academic hospital (defined as a hospital or a health system that sponsors four or more approved medical education programs) (b) one or more faculty practice plans affiliated with the medical school, the affiliated hospital(s), or the accredited academic hospital; and (c) one or more affiliated hospital(s) in which a majority of the physicians on the medical staff consists of physicians who are faculty members and a majority of all hospital admissions are made by physicians who are faculty members.

     

    A faculty member is a physician who is either on the faculty of the affiliated medical school or on the faculty of one or more of the educational programs at the accredited academic hospital. Faculty from any affiliated medical school or accredited academic hospital education program may be aggregated, and residents and non- physician professionals need not be counted. Any faculty member may be counted, including courtesy and volunteer faculty.