The Office of Inspector General (OIG) issued a Proposed Rule on October 2, 2014 that would amend the safe harbors to the Anti-Kickback Statute and the civil monetary penalty (CMP) rules to add new safe harbors to codify statutory changes in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the Patient Protection and Affordable Care Act, that would protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the Anti-Kickback Statute.  The OIG also proposed to codify certain revisions to the definition of “remuneration,” added by the Balanced Budget Act (BBA) of 1997 and ACA and add a gainsharing CMP provision in the OIG’s regulations.

The OIG specifically proposed to amend the safe harbor regulations to the Anti-Kickback Statute by modifying certain existing safe harbors and by adding some new safe harbors.  Some of the proposed changes include:

• 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.

The OIG also proposed to amend 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 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.

These proposed changes and additions by the OIG address several areas that healthcare providers have asked for clarification from the OIG for some time as to potential application of the Anti-Kickback Statute and CMP rules.

The Proposed Rule is scheduled to be published in the Federal Register on October 3, 2014 and available online at http://federalregister.gov/2014-23182.  An unpublished copy of the Proposed Rule is available at:  https://www.federalregister.gov/articles/2014/10/03/2014-23182/fraud-and-abuse-safe-harbors-under-the-anti-kickback-statute-civil-monetary-penalty-rulesregardingutm_campaign=pi+subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Written by: Clay Countryman