Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Limited Remuneration to a Physician

Stark
Stark exception to limited remuneration to a physician 42 CFR 411.357(z)

Anti-Kickback
[No comparable safe harbor]

The remuneration is for the provision of items or services provided by the physician to the entity and does not exceed in the aggregate $5,000 per calendar year as adjusted for inflation on an annual basis.

The compensation is not determined in any manner that takes into account the volume or value of referrals or other business generated by the physician.

The compensation does not exceed the fair market value of the items or services and the arrangement would be commercially reasonable even if no referrals were made between the parties.

Any compensation for the lease of office space or equipment is not determined using a formula based on a percentage of revenue raised, earned, billed, collected, or otherwise attributed to services generated in the office space or through the use of the equipment or based on a per-unit of service rental charges to the extent such charges reflect services provided to patients referred by the lessor to the lessee.

Any compensation for the use of premises or equipment is not determined using a formula based on a percentage of revenue raised, earned, billed, collected, or otherwise attributed to services provided while using the premises or equipment covered by the arrangement or based on per-unit of service fees that are not time-based to the extent such charges reflect services provided to patients referred by the party granting permission to use the premises or equipment covered by the arrangement.

If remuneration to the 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.

Services provided by the physician may be provided through employees whom the physician has hired for the purpose of performing the services, through a wholly-owned entity, or through locum tenens physicians.