As of January 6, 2017, new changes are in effect to the federal Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) rules. The Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule in December that creates new AKS safe harbors, modifies existing AKS safe harbors, and amends the definition of “remuneration” under CMP guidelines.
A second rule published on the same day implements several provisions of the Affordable Care Act (ACA) that allow for the expanded imposition of CMPs for conduct such as failing to give the OIG quick access to documents and ordering or prescribing medication while excluded from Medicare or Medicaid.
With these rules now in effect, providers should consider how the new safe harbors and exceptions to the definition of “remuneration” can be utilized to permit additional business relationships and practices, while remaining mindful of the OIG’s continued focus on fraud and abuse enforcement.
The AKS imposes criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive remuneration in order to induce or reward the referral of business reimbursable under federal health care programs. Congress and the OIG have carved out certain AKS safe harbors to describe various payment and business practices that, although they potentially implicate the AKS, are not treated as fraudulent kickbacks or violations under the statute. The first Final Rule created new safe harbors and revised several existing ones:
In addition to modifying AKS safe harbors, the OIG also created several exceptions to the definition of “remuneration” that allow providers to give free services to beneficiaries without triggering a CMP. Typically, the beneficiary inducement provisions prohibit any person from offering remuneration to Medicare or Medicaid beneficiaries that the offeror knows or should know are likely to influence the selection of particular providers, practitioners, or suppliers. However, the new rule amended the definition of “remuneration” by codifying statutory exceptions added by the Balanced Budget Act of 1997 (BBA) and the ACA:
On the same day it released the rule discussed above, OIG issued a second Final Rule that also affects CMP regulations. This final rule mainly implements statutory provisions of the ACA providing for CMPs, assessments, and exclusions for: failure to grant OIG timely access to records; ordering or prescribing while excluded; making false statements, omissions, or misrepresentations in an enrollment application; failure to report and return an overpayment; and making or using a false record or statement that is material to a false or fraudulent claim. This final rule also reorganized the regulations regarding CMPs, assessments, and exclusions to “improve readability and clarity.”
If you have questions about the federal Anti-Kickback Statute or civil monetary penalty rules, please contact Catie Bitzan Amundsen at email@example.com (612-632-3277) or Julia Reiland at firstname.lastname@example.org (612-632-3280).
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