Important Differences between the Anti-Kickback Statute and Stark Law
Anti-Kickback Statute and Stark Law Team Lead
Former DOJ Attorney
Contact Lynette directlyWhat works in other industries typically does not work in the healthcare industry. It is critical to understand that while it is more than common to pay for business on a quid-pro-quo basis in many other industries, healthcare laws strictly forbid direct compensation for patient referrals.
The Anti-Kickback Statute and the Stark Law are the two federal statutes that are primarily responsible for this prohibition on compensation for referrals. While both statutes are similar in nature, the notable differences between the statutes are outlined below.
- What Is the Anti-Kickback Statute? The Anti-Kickback Statute (AKS) (42 U.S.C. § 1320a-7b(b)) bans anyone from soliciting or receiving remuneration of any kind in exchange for referring a patient for services for which federal health care programs pay or for purchasing an item or service for which federal health care programs pay.
- What Is the Stark Law? The Physician Self Referral Law, commonly referred to as the Stark Law (42 U.S.C. § 1395nn) limits a physician’s ability to refer Medicare or Medicaid patients to a health service provider in which the referring physician (or their immediate family member) has a financial relationship with that entity, and prohibits health service providers from billing Medicare or Medicaid for medical services performed pursuant to a barred referral. There are different entities that oversee the enforcement of Stark Law and these are the Department of Justice (DOJ), the Department of Health and Human Services (HHS), and the Centers for Medicare and Medicaid Services (CMS).
Important Differences
- Applicable Federal Healthcare Programs: The Physician Self Referral Law or Stark Law is limited to Medicare and Medicaid; the federal Anti-Kickback Statute (AKS) applies to all government-funded, including TRICARE and patients under the Department of Labor programs.
- Source of Prohibited Referrals: Whereas the Stark Law is only concerned with referrals from physicians with financial relationships to the provider of the designated health service, the AKS applies to referrals from anyone. That said, however, anyone can violate the federal AKS by illegally referring patients, but only physicians can violate Stark Law’s self-referral prohibitions.
- Type of Services Involved: The Anti-Kickback Statute covers all services or items for which payment is sought from a federal health care program. In contrast, the Stark Law applies only to an express list of “Designated Health Services” (DHS) composed of: (1) clinical laboratory services; (2) physical therapy services; (3) occupational therapy services; (4) outpatient speech-language pathology services; (5) radiology and certain other imaging services; (6) radiation therapy services and supplies; (7) durable medical equipment and supplies; (8) parenteral and enteral nutrients, equipment, and supplies; (9) prosthetics, orthotics, and prosthetic devices and supplies; (10) home health services; (11) outpatient prescription drugs; and (12) inpatient and outpatient hospital services.
- Exclusions: The Anti-Kickback Statute specifies certain optional safe harbors, whereas the Stark Law expressly excludes a number of “exceptions” from the purview of the law. Some of the exceptions are bona fide employment relationship, in-office ancillary services, personal physician services, and others.
- Intent Required to Violate Act: Prosecutors must demonstrate that a person “knowingly and willfully” violated the law in order to prove a violation of the AKS. The Stark Law holds a physician or designated health services (DHS) liable for reimbursing the government for any monies received in violation of the law, but it requires a person to have knowingly violated the law in order to receive a civil monetary penalty.
- Penalties for Violation: The penalties for violation of the Stark Law are limited to civil penalties, such as denial of payment, fines, reimbursement, and False Claims Act liability. In addition to civil sanctions, the Anti-Kickback Statute also provides for criminal punishment. A violation of the AKS constitutes a federal felony punishable by up to 5 years in prison and up to a $25,000 fine for each violation.
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Oberheiden, P.C. is a team of former healthcare prosecutors and experienced trial attorneys who handle healthcare and business litigation throughout the United States. We advise health care providers, business owners, and executives on all complex issues of healthcare law.
Additionally, our healthcare fraud defense attorneys assist health care services providers and businesses under investigation for alleged Qui Tam Lawsuit, Stark Law, False Claims Act, or Anti-Kickback violations.
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If you need assistance with a Stark Law or AKS investigation, you should contact the experienced attorneys at Oberheiden, P.C. Get a free and confidential consultation and benefit from talking to former federal and state prosecutors and experienced litigators.
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Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.