Physicians around the country are familiar with the Federal Anti-Kickback Statute (“AKS”) (42 U.S.C. § 1320a-7b(b)) and the Federal Physician Self-Referral Law, commonly referred to as the Stark Law (“Stark”) (42 U.S.C. § 1395nn). While both are in place to control problematic financial incentives in the health care industry, here are five differences between Stark and AKS:
- Stark is regulated by the Centers for Medicare & Medicaid Services (“CMS”) while the AKS is regulated by the Office of the Inspector General (the “OIG”) for the Department of Health and Human Services. Both CMS and the OIG issue advisory opinions (CMS less frequently than the OIG) to provide guidance on whether certain financial arrangements are prohibited.
- Stark prohibits physicians from referring patients to receive “designated health services” payable by Medicare from entities with which the physician or an immediate family member has a financial relationship unless an exception applies. AKS prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients).
- There are mandatory exceptions to avoid violating Stark, while there are voluntary safe harbors to avoid violating AKS. One of the most common exceptions to Stark is the In-Office Ancillary Services Exception. This exception allows those who are part of a Group Practice, as defined by CMS, to order Designated Health Services from the physicians Group Practice.
- Stark applies to certain healthcare practitioners, not only to physicians, while AKS applies to any referral source.
- Stark is a strict liability statute, which means proof of specific intent to violate Stark is not required. Stark is limited to civil penalties. Penalties for violating Stark include, but are not limited to, (1) liability under the False Claims Act; (2) future exclusion from Medicare or Medicaid reimbursement; and (3) payment of civil penalties up to $15,000.00 and three times the amount of improper payment for each service that a person “knows or should know” was provided in violation of Stark. Violating AKS comes with both civil and criminal penalties. These penalties include, but are not limited to, (1) incarceration up to five years; (2) loss of medical license; and (3) civil fines up to $50,000.00.
Please note that many States have their own Anti-kickback laws in addition to the federal laws discussed above. Ensuring clear understanding of and compliance with both Stark and AKS at both the federal and state level is paramount to health care providers avoiding business and personal risk. For more information on Stark and AKS, please do not hesitate to contact Aaron Black, Esq. at firstname.lastname@example.org.