OIG proposes Anti-Kickback exceptions: 5 things to know

HHS' Office of the Inspector General has issued a proposed rule that would amend the safe harbors to the Anti-Kickback Statute and protect certain payment practices and business arrangements from prosecution and civil sanctions under the civil monetary penalty rules.

Here are five things to know about the OIG's proposed rule.

1. The rule makes a technical correction to the safe harbor for referral service. The safe harbor will revert to the language of the 1999 final rule, which stated the safe harbor precludes protection for payments from participants to referral services that are based on the volume or value of referrals to, or business otherwise generated by, "either party for the other party." 

2. The OIG's proposed rule seeks to protect certain low-risk cost-sharing waivers. In addition, the OIG is seeking comments about expanding this safe harbor to protect waivers under all federal healthcare programs, rather than just waivers of Medicare and state healthcare program beneficiary cost-sharing. 

3. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 amended the Social Security Act by adding a provision that excepts from liability under the Anti-Kickback Statue waivers or reduction by pharmacies, as long as specified conditions are met. The Medicare Prescription Drug, Improvement, and Modernization Act also added an exception to permit certain remuneration between Medicare Advantage organizations and federally qualified health centers.

4. Reflecting the changes to the Social Security Act, the OIG's proposed rule seeks to provide Anti-Kickback safe harbor protection for pharmacies waiving Part D cost-sharing if certain conditions are met.

5. The Balanced Budget Act of 1997 and the Patient Protection and Affordable Care Act include exceptions to the definitions of "remuneration" under the civil monetary penalties law. The OIG's proposed rule seeks to codify the changes.

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