The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS (Final Rule). The Final Rule finalizes all of the anti-kickback statute safe harbors proposed in an October 3, 2014 proposed rule, with certain modifications, and all of the beneficiary inducement CMP exceptions proposed in the Proposed Rule.

With regard to the AKS, the Final Rule finalizes:

  • A technical correction to the existing safe harbor for referral services;
  • Protection for certain cost-sharing waivers, including: pharmacy waivers of cost-sharing for financially needy Medicare Part D beneficiaries, and waivers of cost-sharing for emergency ambulance services furnished by state- or municipality-owned ambulance services;
  • Protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
  • Protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
  • Protection for free or discounted local transportation services that meet specified criteria.

In the Final Rule, the OIG also amends the definition of “remuneration” in the CMP regulations at 42 CFR 1003 by adding certain statutory exceptions for:

  • 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.

According to the OIG, the Final Rule is intended to “enhance flexibility for providers and others to engage in health care business arrangements to improve efficiency and access to quality care while protecting programs and patients from fraud and abuse.” The OIG also notes that it has taken changes in health care payment and delivery into account in finalizing the Final Rule, recognizing that “the transition from volume to value-based and patient-centered care requires new and changing business relationships among health care providers.” Reed Smith is preparing a Client Alert providing additional analysis of the final rule.