Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Isolated Transactions

Isolated Transactions – Current as of March 2021

Stark
Stark exception to the referral prohibition related to compensation arrangements for isolated transactions  42 CFR 411.357(f)  

Anti-Kickback
[No comparable safe harbor]

Isolated financial transactions include a one-time sale of property or a practice, or a single instance of forgiveness of an amount owed in settlement of a bona fide dispute.  

The amount of the remuneration under the isolated financial transaction is consistent with the fair market value of the isolated financial transaction.

 

The amount of remuneration under the isolated financial transaction is not determined in any manner that takes into account the volume or value of referrals by the referring physician or other business generated between the parties.

 

The remuneration is provided under an arrangement that would be commercially reasonable even if the physician made no referrals to the entity.

 

There are no additional transactions between the parties for 6 months after the isolated transaction, except for transactions which are specifically excepted under another Stark exception, and except for commercially reasonable post- closing adjustments that do not take into account the volume or value of referrals or other business generated by the referring physician.

 
An isolated financial transaction that is an instance of forgiveness of an amount owed in settlement of a bona fide dispute is not part of the compensation arrangement giving rise to the bona fide dispute.  
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