Anti-Kickback Statute Stark Law and False Claims Act
The False Claims Act makes it illegal to knowingly make or make a false claim against the government. So, if we were to proceed with the transaction you are proposing, even claims for services submitted to the government for a fee would be a violation of the False Claims Act. As we have seen previously, Fundamental Posts of the False Claims Act (FCA), fca, 31 U.S.C. § 3729 et seq., may be triggered by filing claims related to violations of certain federal laws. This article explains the basics of two of these laws: the Anti-Bribery Act (AKS) and the Stark Law. Penalties for violating the Stark Law: The Stark Law is a strict liability law, which means that proof of a specific intent to violate the law is not required. The Stark Act prohibits the filing or filing of claims that violate legal restrictions on returns. AKS violations may result in FCA liability, as allegations affected by AKS violations are considered false within the meaning of the FCA. Claims for payment to Medicare or Medicaid that include items or services arising from a violation of the Anti-Bribery Act are considered false claims under the False Claims Act, even if the defendant did not have a specific intention to commit a violation of the Anti-Bribery Act.
The Physician Self-Referral Act, commonly referred to as the Stark Act, prohibits physicians from referring patients to receive «designated health services» payable by Medicare or Medicaid from companies with which the physician or an immediate family member has a financial relationship, except in any case. Stark`s Law prohibits the designated health care organization (p. e.g., clinical laboratory, physiotherapy, radiology and other imaging services) to make claims to Medicare for services resulting from a prohibited referral. The Office of the Inspector General provides expert advice. However, the notices (42 CFR Part 1008) are very limited and provide guidance only to specific parties who have requested the OIG`s comments; only for the specific facts set out in the request for an opinion; and only if the specific guidelines of the opinion are followed. In addition, the report does not offer protection against criminal sanctions if the Ministry of Justice considers that a criminal law has been violated. Whistleblowers can also file a civil lawsuit on behalf of the government, which can result in fines of tens of thousands of dollars, plus three times the amount unduly paid to the injured party. Anti-Bribery Act, 42 U.S.C. Section 1320a-7bb) «is a criminal law that prohibits knowingly or intentionally offering or seeking compensation to induce a person to refer to items or services that may be paid for by a federal health program.» United States ex rel. Nunnally v. W. Calcasieu Cameron Hosp., 519 F.
App`x 890, 893 (5th Cir. 2013) (per curiam) (citing 42 U.S.C. § 1320a-7b(b)(1-2); United States ex rel. Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899, 901 (5. Cir. 1997)). In addition, fines for non-compliance are no longer always insurable, so in some cases, health care executives are held personally liable if significant regulatory gaps are discovered. For example, a pharmaceutical company paid more than $591 million to resolve allegations that its sales representatives had paid bribes (via speaker fees) to doctors to convince them to prescribe multiple drugs. There are many other laws, federal and state, that create potential liability for providers and other healthcare companies, including state anti-bribery laws, state self-referral prohibitions (similar to Stark`s federal regulations, but often applicable to all forms of payers).
Businesses and healthcare providers should also be aware of the corporate practice of drug bans that exist in many states and the specific Medicare rules that apply to different types of providers. Some examples of Medicare rules that can cause problems for healthcare companies include the anti-tagging rule, the terms and conditions of participation for different companies, and performance, licensing, or certification standards. When doing business, health care providers must comply with many complex regulations, such as the ban on self-referral by federal doctors (commonly referred to as the Stark Act), the federal Anti-Bribery Act, and countless state fraud and abuse laws that may or may not reflect federal rules. Corporate healthcare companies may be further restricted by the corporate practice of drug bans, cost-sharing bans, notification requirements, Medicare terms and conditions, or certification requirements and billing rules (such as the anti-tagging rule).