Skin Substitute Rebate Compliance Requirements for Doctors under the Anti-Kickback Statute and Safe Harbor Regulations
PICA has become aware of situations in which vendors of skin substitute products offer rebates to doctors who purchase those products. Questions have arisen regarding what legal requirements, if any, are doctors required to comply with to ensure that any rebate payments received do not subject a doctor to the criminal or civil penalties in the Anti-Kickback Statute (AKS).
The AKS imposes criminal and civil penalties if a doctor knowingly receives any remuneration in return for purchasing or ordering any item for which payment may be made by a federal healthcare program, such as Medicare. In short, the AKS prohibits kickbacks between doctors and vendors. “Remuneration” under the AKS specifically includes rebates. However, the AKS contains an exception for certain “discounts” if the discount is properly disclosed and appropriately reflected in the costs claimed or charges made by the doctor to Medicare. This exception is commonly referred to as a “safe harbor” provision.
The Pennsylvania Podiatric Medical Association (PPMA) currently represents more than 875 Doctors of Podiatric Medicine (or podiatrists/DPM) across the Commonwealth of Pennsylvania.
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