What’s the difference between the federal physician self-referral law — commonly referred to as the Stark law — and the antikickback statute? We highlighted some of the main distinctions below.
- Prohibitions. The Stark law prohibits referrals by physicians for designated health services to an entity or a person with which the physician or immediate family member has a financial relationship (unless an exception applies). The antikickback law is broader and prohibits the offering, paying, asking or receiving anything of value (including gifts and discounts) to induce referrals or generate business for any items or services from any program paid for by Federal health care dollars.
- Intent. Stark is strict liability statute and therefore no intent to violate the law is necessary to demonstrate non-compliance (see point 4 below). The antikickback statute, on the other hand, includes an intent element which requires that an entity “knowingly and willfully” commit a prohibited conduct. The Affordable Care Act clarified that government prosecutors do not need to prove that an entity had specific intent to violate the antikickback statute to satisfy the element.
- Penalties. The antikickback statute carries criminal penalties such as, for example, a 5 year prison term per violation in addition to fines of up to $25,000 per violation. Civil and administrative penalties can also be imposed under the antikickback statute. The Stark law is not a criminal statute and only civil penalties, albeit serious, can be imposed.
- Exceptions. The antickickback law has voluntary safe harbors and therefore certain relationships that may not fully satisfy a safe harbor may nonetheless be legal (although an entity may still be investigated). Under the Stark law, however, the exceptions are mandatory, and non-compliance of any one factor could result in a violation.
- Scope. The antickickback statute is broader than the Stark law and covers conduct in all federal health care programs. The Stark law applies to Medicare and Medicaid.
The above list is only a bird’s eye view of the two statutes. Due to complexity of the Stark and antikickback statutes and the pivotal role they play in the healthcare industry, the facts of each transaction or relationship should be carefully analyzed for compliance.
If you have any questions regarding the Stark or antikickback laws or regulations, safe harbors or exclusions, or have other legal questions, please contact us here.