Health Information Management

OIG proposes anti-kickback safe harbors

HIM-HIPAA Insider, November 3, 2014

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The Office of the Inspector General (OIG) recently released a proposed rule in the Federal Register that would amend safe harbors under the anti-kickback statute. The rule also proposed to amend the definition of remuneration as used in the law. The anti-kickback statute mandates criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration for referrals reimbursable under federal healthcare programs.
 
The rule proposed the following changes to the anti-kickback statute:
  • A technical correction to 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 for state- or municipality-owned emergency 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
  • Protection for free or discounted local transportation services that meet specified criteria
 
The rule proposed to amend the definition of remuneration to include certain exceptions for the following:
  • 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
  • Copayment waivers for the first fill of generic drugs
 
The OIG will accept comments on the proposed rule by mail or electronically until 5 p.m. (Eastern) December 2.



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