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    OIG warns pharmacies about drugmaker coupons used in claims to federal payers

    Ned MilenkovichThe U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently estimated that more than two million Medicare Part D beneficiaries use copayment coupons to buy drugs through their federal prescription plans. Patients benefit from drug manufacturer coupons because they enable consumers to opt for expensive brand-name drugs for little to no out-of-pocket copayment cost. Manufacturers benefit from copayment coupons because they may help a brand-name drug keep its market share, once a generic version is approved.

    In September 2014, the OIG issued a report noting that the use of copayment coupons by beneficiaries of federal healthcare programs can lead to increased healthcare costs for the federal government and greater prescription drug costs for healthcare insurers.

    Anti-kickback statute

    The OIG determined that coupons were being used for drugs covered by federal healthcare programs. As discussed below, it is a violation of the anti-kickback statute to offer coupons to induce the purchase of drugs paid for by federal healthcare programs.

    The OIG deemed that current safeguards used by drug manufacturers are unreliable. The OIG found that letters warning pharmacists not to submit claims for federal reimbursement in connection with the coupons and manufacturers’ use of pharmacy claims edits did not prevent the processing of coupons for the purchase of drugs paid for by federal healthcare programs.

    In an accompanying advisory bulletin, the OIG proclaimed that copayment coupons constitute remuneration under the federal anti-kickback statute. As a result, drug manufacturers that purposefully use coupons to induce purchases of prescriptions payable by a federal healthcare program will violate the anti-kickback statute.

    In addition, if the offer of copayment coupons violates the anti-kickback statute, claims for prescriptions resulting from such violations could be construed as fraudulent claims under the False Claims Act.

    Ned Milenkovich, PharmD, JD
    This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with ...

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