Extract to table

Prohibition on Soliciting or Receiving Remuneration Subsection (b)(1) of the AKS provides that whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program, shall be guilty of a felony

The core principles applicable to clinical trial payments are: (a) Research payments must reflect fair market value for legitimate, necessary services rendered in connection with the research; (b) Payments must not be tied, directly or indirectly, to the volume or value of prescribing activity or referrals of patients for items or services payable by federal health care programs; (c) The selection of investigators and sites must be based on legitimate research criteria (e

Failure to satisfy a safe harbor does not mean that an arrangement violates the AKS, but it does mean that the arrangement must be evaluated on a facts-and-circumstances basis under the statute itself

Conversely, failure to comply with a safe harbor does not establish that an arrangement violates the AKS; it merely means that the arrangement must be evaluated under the totality of the circumstances

However, per-patient fees are not free from AKS risk, and the following factors must be considered: Fair Market Value

The grants must be structured to ensure that they do not, and are not perceived to, function as compensation for prescribing activity