The false claims act (FCA), 31 U.S.C. § 3729 (a), is a civil statute that prohibits knowingly submitting false / fraudulent claims to the government for payments. While The Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b, is a criminal statute that prohibits anyone from knowingly / willfully offering, paying or receiving compensation in exchange for a referral for a health care service / health care equipment that is paid by a federal health care program for Medicare, Medicaid, Tricare, and the alike.
The Patient Protection and Affordable Care Act (PPACA) which will allow FCA to push for civil liability to include violations of the AKS.
As attorneys have argued in the past that AKS can serve as the basis for liability under the FCA because of the fact that health care insurance programs would not have paid the claim had it known of the improper referral and kickback relationship. The reach of AKS has been extended due to a fine print disclaimer stating that an individual must certify that they complied with all applicable laws before submission of a claim.
Can the legislation do without the general 'intent' requirement?
With the recent amendment, it has been identified that the intent requirement has been removed from AKS. However, something that has left everyone baffled is that Anti-Kickback Statutes are now per se violations of the False Claims Act where a person need not have actual knowledge of falsifying a document.
Now the fear that runs through the compliance officers is that this change might overturns a series of judicial interpretations. However, no, it won’t as this removal of the specific intent requirement does not mean that general intent has been removed from the AKS. The only thing this does for the US government is that government no longer has to prove a person had the specific intent to non-compliance with AKS.
Additionally, the Sunshine Act has not only increased public awareness of the money flowing from various industries such as pharma, medical device industry, the physicians and the like but have also increased the government’s access to such data.
In absence of a general intent requirement, the plaintiff’s burden would be less as proving that the defendant was on that computer system, in that office premises on such date and time, the rest will be very easy to prove his / her case.
However, it is only because of the general intent requirement which requires that the plaintiff has the burden to prove the defendant’s state of mind and wilfulness. Thus, it again goes to prove the importance of a compliance program.
Conclusion
It looks like being careless is no longer a defense for a person / physician / coder to make a mistake for whatever reason it may be for. With the inclusion subsection (h) of the AKS, this states that “With respect to violations of this section, a person need not have actual knowledge of this section or specific intent to commit a violation of this section”. Thus, while the government must prove intent to establish an AKS violation, PPACA made intent easier to prove the same.
However, the plaintiff will still have to prove that the perpetrator “knowingly and willfully” solicited / received, or offered / paid, remuneration in return for a referral or a purchase for which payment may be made. It is enough that a defendant knew, or should have known.