Pharmaceutical Coupons May Be an AKS Risk

The Office of Inspector General (OIG) issued on September 18 a Special Advisory Bulletin (SAB) and an Office of Evaluations and Inspections (OEI) report that discussed the potential Anti-kickback issues for pharmaceutical companies and pharmacies associated with offering co-payment and/or discount coupons.

The SAB defines co-payment coupons as “any form of direct support offered by a manufacturer … to reduce or eliminate out-of-pocket costs.”

Certified Professional Compliance Officer - CPCO

According to OIG, as addressed in the OEI report and the SAB, when offering “copayment coupons” or discounts related to pharmaceutical therapies, there “is the potential for these coupons to induce both physicians and patients to use more-expensive brand-name drugs when less-expensive and equally effective generic options are available.” OIG’s SAB expressed apprehension that:

… “the continued use of copayment coupons without the implementation of effective mechanisms to prevent their use by federal program beneficiaries, improved reliability of claims edits, and other solutions to make the coupons “universally identifiable,” creates risk under the federal Anti-Kickback Statute (AKS) (42 U.S.C. § 1320a-7b(b)).”

Protect Your Practice

Michael D. Miscoe, JD, CPC, CASCC, CUC, CCPC, CPCO, of AAPC’s National Advisory Board, Legal Advisory Board, and AAPC Ethics Committee says:

… be aware of the compliance risks associated with these coupons in the event that drug reps attempt to supply your practice with such coupons as an incentive to physicians to order more costly drugs. Even if this doesn’t occur, knowledge of this issue might help prepare you for potential questions by patients seeking these coupons.

OIG also warns pharmacies that accepting manufacturer’s coupons from federal program beneficiaries may result in liability under AKS, the beneficiary inducement Comprehensive Medical Plan, and the False Claims Act (31 U.S.C. § 3729).

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Michelle Dick
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Michelle Dick

Executive Editor at AAPC
Michelle A. Dick has been executive editor for AAPC for over seven years. Prior to her work at AAPC, she was editor-in-chief at Eli Research and Element K Journals, and disk ad coordinator, web designer/developer, and graphic artist at White Directory Publishers, Inc. Dick has a Bachelor of Science in Graphic Design from the State University of New York - Buffalo State and is a member of the Flower City Professional Coders in Rochester, N.Y.
Michelle Dick
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About Has 135 Posts

Michelle A. Dick has been executive editor for AAPC for over seven years. Prior to her work at AAPC, she was editor-in-chief at Eli Research and Element K Journals, and disk ad coordinator, web designer/developer, and graphic artist at White Directory Publishers, Inc. Dick has a Bachelor of Science in Graphic Design from the State University of New York - Buffalo State and is a member of the Flower City Professional Coders in Rochester, N.Y.

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