The statutory framework of healthcare fraud defense primarily centers around 18 U.S.C. § 1347, which criminalizes schemes to defraud federal health care programs. To secure a conviction under this statute, the government must establish that the defendant knowingly devised or participated in a scheme intended to defraud any healthcare benefit program and executed it through one of several means outlined by the law.
The False Claims Act (FCA), 31 U.S.C. §§ 3729-3733, is another critical statute that often intersects with healthcare fraud cases. The FCA imposes liability on any person or entity who knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim; conspires to defraud the government by getting a false or fraudulent claim paid or approved; or has possession, custody, or control of property or money used or to be used by the Government and knowingly conceals or retains such property or money. In healthcare fraud cases, these provisions are often invoked when providers submit claims for services that were not rendered or overstate the value of services provided.
Medical necessity disputes also play a significant role in healthcare fraud defense strategies. When challenging FCA allegations based on lack of medical necessity, defendants must establish that the treatment provided was medically necessary according to prevailing standards and guidelines. This often involves expert testimony from physicians familiar with the relevant clinical practices to demonstrate that the services rendered were appropriate under the circumstances.
The Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b, prohibits offering, paying, soliciting, or receiving anything of value in exchange for referrals or arranging business involving federal healthcare programs. Violations can lead to civil monetary penalties and exclusion from participation in Medicare, Medicaid, and other federal health care programs. AKS violations are often alleged alongside FCA claims, necessitating a robust defense strategy that scrutinizes the nature and intent behind financial arrangements between healthcare providers.
The Stark Law, 42 U.S.C. § 1395nn, further complicates matters by prohibiting physicians from making referrals for certain designated health services to entities with which they have a financial relationship, unless an exception applies. Like AKS violations, Stark Law allegations can result in civil penalties and exclusion from federal healthcare programs if not properly addressed. A successful defense may involve demonstrating that one of the numerous exceptions codified at 42 C.F.R. Part 411 apply to the challenged arrangement.
HHS-OIG (Health & Human Services - Office of Inspector General) investigations are a significant threat to healthcare providers and require immediate attention when initiated. HHS-OIG has broad investigative powers, including the authority to subpoena records and interview witnesses without