Federal Fraud and Abuse Update
Updated: Jun 21, 2022
On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) published the final rule codifying revisions and additions to the Anti-Kickback Statutes’ (“AKS”) safe harbors and Civil Monetary Penalties Law’s (“CMPL”) exceptions. Pursuant to this final rule, effective January 6, 2017, new safe harbors have been added to the AKS for: (1) certain cost-sharing waivers for pharmacy and ambulance services; (2) discounts as part of the Medicare Coverage Gap Discount Program; and (3) free or discounted local transportation services to established patients. In addition, new exceptions have been added to the CMPL for: (1) copayment reductions for certain hospital outpatient department (“HOPD”) services; (2) services promoting access to care while posing a low risk of harm; (3) coupons, rebates and other retailer rewards programs; (4) discounts and waivers for the financially needy; and (5) copayment waivers for a patient’s first fill of a generic drug. Additional information regarding these safe harbors and exceptions, including the specific criteria necessary to meet each, is available on the federal register at: https://www.federalregister.gov/documents/2016/12/07/2016-28297/medicare-and-state-health-care-programs-fraud-and-abuse-revisions-to-the-safe-harbors-under-the.