ARTICLE
28 October 2014

OIG Proposes New "Safe Harbor" Rule

The HHS, under the authority of the OIG, proposed a new regulation that would modify existing safe harbors to the anti-kickback law and also add new protections.
United States Food, Drugs, Healthcare, Life Sciences
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The Health and Human services department, under the authority of the Office of Inspector General (OIG), recently proposed a new regulation that would modify existing safe harbors to the anti-kickback law and also add new protections.

The proposed changes relate to the following safe harbor topics:

  • Referral services;
  • Cost-sharing waivers, including pharmacy waivers and emergency ambulance service waivers;
  • Remuneration between Medicare Advantage organizations and federally qualified health centers;
  • Discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
  • Free or discounted local transportation services.

The rule proposal also seeks to modify the definition of remuneration by adding certain statutory exceptions.

Comments to the rule proposal are due no later than December 2, 2014.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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