Emerging Information on Rebates for Skin Substitutes

Recently, information has emerged about taking a closer look at important regulations regarding rebates to doctors on skin substitute products. In particular, J. Kevin West and Jamie L. Riley, recently published a blog post with PICA outlining their understanding of the compliance requirements in relation to the Anti-Kickback Statute and safe harbor regulations.¹ They discussed necessary steps in the process that a doctor must take to avoid exposure to potential civil or criminal penalties when a vendor of a skin substitute product offers a rebate to a purchasing doctor.

According to the blog, the Anti-Kickback Statute prohibits kickbacks between doctors and vendors, which does include rebates. They point out that exceptions exist under very specific circumstances covered by the “safe harbor” provision.¹ The authors shared that rebates from vendors of skin substitutes may be considered as an exception “discount” if they meet specific criteria and if the doctor satisfies certain disclosure requirements. This includes actions necessary from both the vendor and the doctor.¹

The authors of the blog “summarize, (that) the key takeaways for a doctor receiving rebates from a vendor, such as vendor selling skin substitute products, are as follows:

1. A skin substitute rebate can fall into the safe harbor provisions of the AKS if it is:
   • In the form of a check; and
   • The terms of the rebate are fixed and disclosed in writing to a doctor at the time the skin substitute is purchased, but the rebate is not given at the time of the sale; and
   • The doctor provides, upon request by government agency, the invoice from the manufacturer or seller documenting the terms of the discount.
2. A doctor cannot “double recover” for the rebate and Medicare reimbursement. The charges to Medicare should be adjusted to reflect the rebate.
3. The rebate does not need to be preemptively disclosed if the doctor/practice is one in whose name the claim for payment is made to Medicare for the skin substitute product. Instead, disclosure of the rebate should be made upon request by the proper government agency.
4. Doctors should be aware that simply following the statute does not exempt potential investigation and liability.”¹

They recommend consulting legal counsel with questions. The detailed and complex nature of these regulations and exceptions is vital for doctors to examine and take action to comply with. Have readers of Podiatry Today seen any other guidance on this important issue?

Dr. Spector is a Fellow of the American College of Foot and Ankle Surgeons and the Immediate Past President of the American Association for Women Podiatrists. She is the Assistant Editorial Director for Podiatry Today, WoundSource and the Podiatry Learning Network. 

Disclaimer: The views and opinions expressed are those of the author(s) and do not necessarily reflect the official policy or position of Podiatry Today or HMP Global, their employees and affiliates. Any content provided by our bloggers or authors are of their opinion and are not intended to malign any religion, ethnic group, club, association, organization, company, individual, anyone or anything. This blog is informational only and does not constitute legal advice.

Reference

1.    West JK, Riley JL. Skin substitute rebate compliance requirements for doctors under the Anti-Kickback Statute and safe harbor regulations. PICA Insights. Available at: https://blog.picagroup.com/en/blog/skin-substitute-rebate-compliance-requirements-for-doctors-under-the-anti-kickback-statute-and-safe-harbor-regulations . Published May 27, 2022. Accessed June 23, 2022.