On December 7, 2016, the Office of Inspector General (OIG) issued two final rules revising the safe harbors under the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) Rules. The OIG finalized a series of new safe harbors proposed in October 2014 to address beneficiary inducements, in other words, benefits given to Medicare/Medicaid beneficiaries that might influence their choice of Medicare/Medicaid provider. The new safe harbors would permit providing the following to beneficiaries (subject to the requirements of the safe harbors):
- certain cost-sharing waivers, including pharmacy waivers for financially needy beneficiaries and waivers by State or municipality-owned emergency ambulance services;
- certain remuneration between Medicare Advantage organizations and federally qualified health centers;
- discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
- free or discounted local transportation services.
The OIG also amended the definition of “remuneration” in the CMP Rules to exclude a number of benefits from the definition of “remuneration” which means these may be provided without violating the prohibition on beneficiary inducement (again subject to the requirements of the Rules):
- copayment reductions for hospital outpatient department services;
- remuneration that poses a low risk of harm and promotes access to care;
- coupons, rebates, or other retailers reward programs;
- remuneration to financially needy individuals; and
- copayment waivers for the first fill of generic drugs.
The OIG reorganized the CMP Rules to improve readability and clarity and to reflect expanded governmental enforcement authority granted by the Affordable Care Act to impose civil monetary penalties, assessments, and exclusion for the following:
- failure to grant OIG timely access to records;
- ordering or prescribing while excluded;
- making false statements, omissions, or misrepresentations in an enrollment application;
- failing to report and return an overpayment; and
- making or using a false record or statement that is material to a false or fraudulent claim.
The CMP Rules allow providing remuneration to a beneficiary if the value is “nominal.” The OIG issued a Policy Statement Regarding Gifts of Nominal Value updating the definition of “nominal value” to $15 per item or $75 in the aggregate per patient on an annual basis.
The new safe harbors for beneficiary inducements will be helpful to organizations focusing on coordinated or integrated care that depends on patient engagement. As always, a careful factual and legal analysis is required for the application of any safe harbor.