On October 2, the Office of Inspector General of the Department of Health and Human Services (OIG) released a proposed rule to add to and amend the existing “safe harbors” to the federal anti-kickback statute (AKS). Although some of the rule’s content is entirely new, portions of it officially implement changes already established under the Affordable Care Act. 

The AKS prohibits the knowing and willful offer, payment, solicitation, or receipt of remuneration for the referral of an individual for healthcare services that are paid for under a federal health care program (including Medicare and Medicaid). Violation of the AKS is a felony punishable by fines of up to $25,000 and five years’ imprisonment. The various safe harbors to the AKS exempt certain arrangements and activities from liability. 

The OIG’s proposed changes include: 

  • Protecting waivers of cost-sharing by Medicare Part D pharmacies and certain emergency ambulance services; 
  • Protecting remuneration between a federally qualified health center and a Medicare Advantage organization; 
  • Protecting drug manufacturer discounts for Medicare Coverage Gap Discount Program beneficiaries; and
  • Protecting free and discounted local transportation services for patients, subject to certain conditions. 

In addition to adding to and amending the safe harbors under the AKS, the proposed rule seeks to amend the definition of “remuneration” under the Civil Monetary Penalty Law by providing exceptions to the definition. Under this definition, remuneration “includes the waiver of coinsurance and deductible amounts (or any part thereof) and transfers of items or services for free or for other than fair market value.” The OIG’s proposed rule seeks to add exceptions to the definition of remuneration for: 

  • Reductions of copayments for certain hospital outpatient services; 
  • Remuneration that promotes access to care and poses a low risk of harm; 
  • Retailer reward programs that satisfy certain requirements; 
  • Provision of free or below-market items or services to financially needy individuals; and 
  • Waivers of copayments for the first fill of a generic drug. 

Public comments to the proposed rule are due by December 2, 2014.