Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Fair Market Value Compensation

Fair Market Value Compensation – Current as of March 2021

Stark
Stark exception to the referral prohibition related to compensation arrangements for fair market value compensation 42 CFR 411.357(l)

Anti-Kickback
[No comparable safe harbor]

The arrangement is between an entity and a physician (or an immediate family member) or any group of physicians (regardless of whether the group meets the definition of a group practice) for the provision of items or services or for the lease of office space or equipment  by the physician (or an immediate family member) or group of physicians to the entity, or by the entity to the physician (or an immediate family member) or a group of physicians.

 

The arrangement is in writing, signed by the parties, and covers only identifiable items, services, office space, or equipment.  The writing specifies the items, services, office space, or equipment covered and the compensation to be provided under the arrangement.

 

 An arrangement may be for any period of time and contain a termination clause. An arrangement may be renewed any number of times if the terms of the arrangement and the compensation for the same items, services, office space, or equipment do not change. Other than an arrangement that satisfies all of the conditions of the Limited Remuneration to a Physician exception, the parties may not enter into more than one arrangement for the same items, services, office space, or equipment during the course of the year.

 

The compensation must be set in advance, consistent with fair market value, and not determined in any manner that takes into account the volume or value of referrals or other business generated by the referring physician. Compensation for the rental of office space or equipment may not be determined using a formula based on-- (i) A percentage of the revenue raised, earned, billed, collected, or otherwise attributable to the services performed or business generated in the office space or to the services performed on or business generated through the use of the equipment; or (ii) Per-unit of service rental charges, to the extent that such charges reflect services provided to patients referred by the lessor to the lessee.

 

The arrangement would be commercially reasonable even if no referrals were made between the parties.

 

The arrangement does not violate the anti-kickback statute.

 

The services to be performed under the arrangement do not involve the counseling or promotion of a business arrangement or other activity that violates a Federal or State law.

 
If remuneration paid to the physician or the group of physicians is conditioned on the physician’s or group’s physicians’ 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.  
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