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LEGAL ALERT
Healthcare Regulatory Compliance
Amendments to Exceptions and Safe Harbors To Stark Act and Anti-kickback Statute
ALEXANDER LEBEDINSKI, ESQ.
Most if not all of the various compensation arrangements between physicians, hospitals and other providers of healthcare items and services present a host of healthcare regulatory compliance, business and legal issues, and must be structured, or restructured, to comply with Federal and State laws and regulations, including the Physician Self-Referral Law (Stark Act) prohibitions on self-referrals and the Anti-Kickback Statute (AKS). The U.S. Department of Health and Human Services published amendments to certain exceptions and safe harbors, as well as issued new exceptions and safe harbors, to the Stark Act and the AKS. Most of the amended and new provisions became effective on January 19, 2021. This article provides a general summary of these regulatory changes. It should be noted that the amendments and newly issued exceptions and safe harbors each contain a number of compliance requirements which we do not fully address in this article, but which are important in determining compliance of any particular arrangement.
Anti-Kickback Statute
The AKS prohibits anyone (that is, health care providers and non-providers) to knowingly and
willfully solicit, receive, offer or pay any remuneration (including any kickback, bribe or rebate) directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, among other things,the referring or arranging for or recommending the purchasing, leasing, or ordering of items or services reimbursable by a federal healthcare program. It is a criminal statute which requires proof of intent to induce referrals through the payment of remuneration in one form or another. The AKS has been interpreted to cover any arrangement where one p ur p o s e o f t h e r e m un e r a t i o n w a s t o o b t a in m o n e y f o r the referral of services or to induce further referrals.
1. New Safe harbors.
a. Value-Based Arrangements:
ii. Three (3) safe harbors, to protect remuneration between participants in value-based arrangements based on the type of remuneration protected, level of financial risk assumed by the parties and types of safeguards. All of these safe- harbors have numerous compliance requirements, which increase with the level of financial risk undertaken.