We continue to receive questions from podiatry practices regarding the use of and billing for amniotic fluid injections for musculoskeletal purposes. We recently published an article, “Caveat Emptor Vendor: Skin Substitutes & Injectable Amniotic Fluid” that details some real-life examples of the risk providers incur if they fail to do proper due diligence in these situations. In the article below, we continue the conversation around amniotic fluid injections by answering three of the most asked questions so you can make informed decisions at your practice.

In the past year, we have seen a dramatic uptick in audits and overpayment claw backs involving two high-dollar products: skin substitutes for wound care and injectable amniotic fluid used for musculoskeletal conditions. While there is no question that these products work, practitioners are often guilty of listening uncritically to sales pitches by vendors who promise high reimbursement and certain payer coverage. Failure to conduct due diligence on these products puts providers at high financial risk because of the substantial cash outlay required to purchase the products, typically upfront.

Written by: J. Kevin West & Jamie L. Riley

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.