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    Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Personal Service Arrangements and Physician Incentive Plans

    Personal Service Arrangements – Current as of November 2017

    Stark
    Stark exception to the referral prohibition related to compensation arrangements for personal service arrangements Click the above link see how this section was amended in January 2016. Amendments also are incorporated below.

    Anti-Kickback
    Safe harbor for remuneration from an entity under an personal service arrangement or management contract

    The arrangement is set out in writing, is signed by the parties, and specifies the services covered by the arrangement.

     

    The arrangement(s) covers all of the services to be furnished by the physician (or an immediate family member of the physician) to the entity. This requirement is met if all separate arrangements between the entity and the physician and the entity and any family members incorporate each other by reference or if they cross-reference a master list of contracts that is maintained and updated centrally and is available for review by the Secretary of HHS upon request. The master list must be maintained in a manner that preserves the historical record of contracts. A physician or family member can "furnish" services through employees whom they have hired for the purpose of performing the services; through a wholly-owned entity; or through, locum tenens physicians, except that the regular physician need not be a member of a group practice.

    The agency agreement covers all of the services the agent provides to the principal for the term of the agreement and specifies the services to be provided by the agent. If the agency agreement is intended to provide for the services of the agent on a periodic, sporadic or part-time basis, rather than on a full-time basis for the term of the agreement, the agreement specifies exactly the schedule of such intervals, their precise length, and the exact charge for such intervals.

    The aggregate services covered by the arrangement do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement(s).

    The aggregate services contracted for do not exceed those which are reasonably necessary to accomplish the commercially reasonable business purpose of the services.

    The duration of each arrangement is for at least 1 year. To meet this requirement, if an arrangement is terminated with or without cause, the parties may not enter into the same or substantially the same arrangement during the first year of the original arrangement.

    The term of the agreement is for not less than one year.

    The compensation to be paid over the term of each arrangement is set in advance, does not exceed fair market value, and, except in the case of a physician incentive plan, is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties.

    The aggregate compensation paid to the agent over the term of the agreement is set in advance, is consistent with fair market value in arms-length transactions and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare or a State health care program.

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

    The services performed under the agreement do not involve the counseling or promotion of a business arrangement or other activity that violates any state or federal law.

    If the arrangement expires after a term of least 1 year, a holdover arrangement immediately following the expiration of the agreement satisfies the requirements, if the following conditions are met: i) the arrangement met all the conditions of this section when the arrangement expired; ii) the holdover arrangement is on the same terms and conditions as the immediately preceding arrangement; and iii) the holdover arrangement continues to satisfy all the conditions of this section..

     

     

    Physician Incentive Plans -- Current as of January 2016

    Stark
    Stark exception to the referral prohibition related to compensation arrangements for incentive plans between an entity and a physician No change

    Anti-Kickback
    [No comparable safe harbor]

    In the case of a physician incentive plan between a physician and an entity (or downstream contractor) that meets the requirements for a personal service arrangement, the compensation may be determined in a manner (through a withhold, capitation, bonus, or otherwise) that takes into account directly or indirectly the volume or value of any referrals or other business generated between the parties.

     

    No specific payment is made directly or indirectly under the plan to a physician or a physician group as an inducement to reduce or limit medically necessary services furnished with respect to a specific individual enrolled with the entity.

     

    Upon request of the Secretary of HHS, the entity provides the Secretary with access to information regarding the plan (including any downstream subcontractor plans), in order to permit the Secretary to determine whether the plan is in compliance with this section.

     

    In the case of a plan that places a physician or a physician group at substantial financial risk as defined in Sec. 422.208, the entity (and/or any downstream contractor) complies with the requirements concerning physician incentive plans set forth at Sec. 422.208 and Sec. 422.210 of this chapter.