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# Attorneys Explain Antikickback Rule
- URL: https://www.fdaweb.com/attorneys-explain-antikickback-rule/
- Published: 2016-12-15T12:00:00.000Z
- Updated: 2026-09-14T21:55:49.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137579

The HHS Inspector General finalized 12/7 a rule amending the safe harbor regulations under the federal healthcare program antikickback law and established exceptions to the civil monetary penalty prohibiting remuneration to Medicare and Medicaid beneficiaries. Attorneys **Alan Kirschenbaum** and **David Gibbons** (Hyman, Phelps & McNamara) [write](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2016/12/oig-finalizes-antikickback-law-safe-harbors-and-cmp-rules-that-would-offer-additional-protections-fo.html?ref=fdaweb.com) in their firm’s *FDA Law Blog* that the final rule changes existing safe harbors and adds new ones, while also adding new exceptions to the beneficiary inducement civil monetary penalty. The final rule is effective 1/6/17\. The attorneys explain key provisions of interest to drug and medical device companies, including: 

- cost-sharing waivers by pharmacies;
- Medicare coverage gap discount program;
- local transportation;
- other safe harbors;
- access to care/low risk of harm
- coupons or rewards from a retailer;
- free or discounted items or services where financial need exists; and
- other civil monetary penalty provisions.