Extract to table

952) — Potentially Applicable Congress directed the OIG to promulgate regulations specifying payment practices that shall not be treated as criminal offenses under the AKS

Failure to meet every element of a safe harbor does not necessarily mean that an arrangement violates the AKS; it means only that the arrangement does not have the benefit of safe harbor protection and must be evaluated on a case-by-case basis under the totality of the circumstances

" Specifically, for non-publicly traded entities, the safe harbor requires, among other conditions: (i) no more than 40% of the value of the investment interests may be held in the aggregate by investors who are in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity; (ii) no more than 40% of the entity's gross revenue related to the furnishing of healthcare items and services in the previous fiscal year or twelve-month period may come from referrals, items, or services furnished to investors; (iii) the terms on which an investment interest is offered to a passive investor who is in a position to make or influence referrals must be no different from the terms offered to other passive investors; (iv) the terms on which the investment interest is offered must not require the investor to make referrals to the entity; (v) the entity must not loan funds to or guarantee a loan for an investor who is in a position to make referrals if the loan or guarantee is used to obtain the investment interest; and (vi) the return on the investment must be directly proportional to the amount of the capital investment

If a Stark Law violation is identified, the 60-day repayment clock begins to run, and AHT must either return the overpayment through the standard process or make a voluntary self-disclosure through the CMS Self-Referral Disclosure Protocol