Proposed Rule Would Expand Safe Harbors under the Anti-Kickback Statute Safe and Revise Civil Monetary Penalty Rules

Last week, the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) proposed a rule that would amend the safe harbors to the anti-kickback statute and the civil monetary penalty (CMP) rules.

Proposed changes to the anti-kickback statute and added safe harbors to certain statutory protections include:

  • 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 Medicate 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.

Proposed changes to the civil monetary penalty rules include amending the definition of "remuneration" in the CMP regulations by adding certain statutory exceptions for:

  • copayment reductions for certain hospital outpatient department services;
  • certain remuneration that posed 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.

In addition, the proposed rule would codify the Gainsharing CMP by interpreting terms used in that statute and adding a definition of "hospital" to the regulations.

The proposed rule was published in the October 3, 2014, Federal Register with a comment period ending at December 2, 2014.

We will keep an eye on this proposed rule and will provide any updates as we learn of them.

If you have any questions please do not hesitate to contact one of our professional consultants.