The False Claims Act (FCA) imposes liability on one who, among other things, “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval.” While the FCA does not define what makes a claim “false or fraudulent,” courts have held the FCA prohibits both factually false claims (e.g., claims that allegedly misstate the procedures or services rendered) and legally false claims (e.g., claims that falsely certify, either explicitly or implicitly, compliance with applicable statutes, regulations, or contractual provisions).

In several recent cases, relators have alleged violations of the FCA based on allegedly false certifications that services submitted for Medicare and Medicaid reimbursement were medically necessary. Title XVIII of the Social Security Act, which governs Medicare, states that payment shall not be made by Medicare “for any expenses incurred for items or services” that “are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” 42 U.S.C. §1395y(a)(1)(a). Thus, physicians and medical providers who seek reimbursement under Medicare generally must “certify the necessity of the services and, in some instances, recertify the continued need for those services.” 42 C.F.R. 424.10(a).