OIG Revises Safe Harbors under Anti-Kickback Statute

Effective January 6, 2017, the Department of Health & Human Services, Office of Inspector General (OIG) has amended the Anti-Kickback Statute to add new safe harbors that protect certain payment practices and business arrangements from sanctions. OIG also amended the Civil Monetary Penalty (CMP) rules by codifying revisions to the definition of “remuneration.”

Specifically, the rule incorporates into regulations safe harbors for payment and business practices permitted under existing law and adds new safe harbors pursuant to OIG’s authority to protect practices OIG deems a low risk to federal health care programs. Among the changes are a technical correction to the existing safe harbor for referral services, protection for certain cost-sharing waivers, including emergency ambulance services furnished by state- or municipality-owned ambulance services, and protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers. Additionally, the rule adds a new safe harbor for free and discounted local transportation made available by an “eligible entity” to “established patients,” provided certain specific conditions are met. This transportation safe harbor follows numerous OIG advisory opinions on the subject issued over the years. (See the enclosed Alert).

OIG also amended the definition of “remuneration” in CMP rules by implementing and codifying new and existing exceptions. These exceptions include copayment reductions for certain hospital outpatient department services; certain remuneration that poses a low risk of harm and promotes access to care; coupons, rebates, or other retailer reward programs that meet specified requirements; certain remuneration to financially needy individuals; and copayment waivers for the first fill of generic drugs.