Are you a pharmaceutical manufacturer that offers copayment coupons to insured patients in order to limit their copayments for branded drugs? If so, it is critical that you review a recent bulletin issued by the Department of Health and Human Services' Office of Inspector General (OIG).
OIG's main concern is with the anti-kickback statute, which makes it a criminal offense to knowingly and willfully offer, pay, solicit or receive payments to induce the referral or generation of business reimbursable by a Federal health care program.
By coupons, OIG means print coupons, debit cards, electronic coupons and direct reimbursements.
Manufacturers that fail to take steps to ensure that their coupons don't induce the purchase of drugs paid for by Medicare Part D (or other Federal health care program items) are at risk for sanctions. Among other things, OIG recommends that manufacturers make their coupons more transparent to avoid improper inducements and that manufacturers consider giving to independent charities that financially support patients without regard to a particular medication.
Finally, pharmacies that accept improper coupons may themselves be subject to sanctions under the anti-kickback statute and the False Claims Act, among other things.
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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