Medicare, Medicaid, and other federal health care programs rely upon medical providers to exercise independent judgment and focus solely on the best interests of patients in making treatment decisions. When a physician or other health care provider selects a treatment course because of a personal financial benefit, that decision is not necessarily in the patient’s best interests and can lead to increased costs, unnecessary procedures or services, and/or harm to a vulnerable patient population. This, in turn, can result in federal health care programs paying out millions of dollars’ worth of improper and fraudulent payments to providers.
To protect patients and the precious dollars allocated to government health care programs, the federal government enacted three powerful laws: the Medicare and Medicaid Anti-Kickback Statute, the Stark Law, and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Many states have followed suit and enacted similar prohibitions. All three laws are criminal statutes, but Congress and the courts have deemed that a violation of one of these laws renders an offending provider’s claims to government health care programs false or fraudulent, thus in violation of the civil False Claims Act (FCA) as well.
The Anti-Kickback Statute is the popular name for The Medicare and Medicaid Fraud and Abuse Statute, 42 U.S.C. § 1320a-7b(b). The AKS is a federal criminal law that prohibits offering or accepting kickbacks intended to generate health care business. Violation of the AKS is a felony. And punishable by ten years in jail and fines of $100,000 per violation.
Violation of the AKS triggers liability under the Civil Monetary Penalties Law. The CMPL carries penalties of up to $50,000 per kickback, in addition to three times the amount of the remuneration. It also makes the resulting bills to the government false under the False Claims Act, making the violator responsible for three times the value of the bills, and a False Claims Act Penalty of up to $23,000 per bill.
The AKS prohibits anyone from requesting, receiving, offering, or paying kickbacks intended to generate health care business.
Health And Human Services Office of Inspector General has created 34 regulatory safe harbors. The regulatory safe harbors are listed at 42 C.F.R. §§ 1001.952(a)-(kk). Safe harbors protect certain payment and business practices that could otherwise implicate the AKS from criminal and civil prosecution. An arrangement is only protected if it fits squarely in the safe harbor and satisfies all of its requirements.
Similarly, the Stark Law, 42 U.S.C. 1395nn, prohibits patient referrals where the referring physician has a financial interest in the health care provider or entity to which the patient is being referred. Unlike the AKS, the Stark Law is a “strict liability” statute, meaning that one need not have intended to violate the law in order to be held accountable under it. The Stark Law covers referrals for a wide variety of services (referred to as “designated health services” in the statute):
Congress enacted EKRA, the Eliminating Kickbacks in Recovery Act of 2018, to fight patient brokering and recovery profiteering. EKRA prohibits accepting or paying kickbacks for referrals to recovery homes, clinical treatment facilities, or laboratories. As a result, EKRA promises to help stem the tide of opioid related fraud.
EKRA operates by prohibiting any recovery home, clinical treatment facility, or laboratory from paying kickbacks to anyone. Notably, EKRA applies to all laboratories whether or not they perform substance abuse testing. For example, it would apply to a hospital laboratory that tests only hospital patients.
In many respects EKRA is similar to the AKS. However there are some notable differences:
Together the AKS and the Stark Law are powerful tools to root out corruption in medical decision-making throughout the health care system. Whistleblowers, including several represented by our attorneys, have been instrumental in exposing kickback and self-referral schemes around the country by filing qui tam complaints under the FCA. Here are just a few examples:
The above are just some examples of the many different types of AKS and Stark Law violations. Both statutes have numerous exceptions and safe harbors that should be carefully analyzed by an experienced practitioner. If you think that you have information relating to violations of either law, please contact us for a free, confidential consultation.
