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.”
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).

Certified Professional Compliance Officer - CPCO

Michelle Dick
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Michelle A. Dick, BS, is a freelance content specialist, providing writing, editorial expertise, and graphic imagery to clients. Prior to becoming a free agent, she was an executive editor for AAPC, editor-in-chief at Eli Research, and editor at Element K Journals. After earning a Bachelor of Science from the State University of New York at Buffalo State, Dick entered the publishing industry as a graphic artist, ad coordinator, and web designer for White Directory Publishers, Inc.

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