OIG Warns Pharmaceutical Manufacturers and Pharmacies About Drug Copayment Coupons

The HHS Office of Inspector General released a Special Advisory Bulletin regarding pharmaceutical manufacturer copayment coupons, and the potential violations of the anti-kickback statute and False Claims Act when such coupons are used to fund copayments for drugs paid for by Medicare Part D.   The anti-kickback statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward the referral or generation of business reimbursable by any Federal health care program.

The Bulletin cites to a report by Office of Evaluation and Inspections (OEI) which concluded that the measures pharmaceutical manufacturers have in place to prevent use of the coupons for copayment for drugs covered by Part D may not be sufficient.

The Bulletin notes that currently manufacturers have notices on coupons that Federal program beneficiaries are not eligible to use the coupons; however such notices are not used on all coupon formats by all manufacturers.  Also, according to the OEI report, the use of claims edits may not reliably identify all claims submitted in connection with drugs paid for by Part D.   Ultimately, the OEI recommended CMS work with industry stakeholders on the coupons and claims edits issues.  The OIG concluded the bulletin with a warning that regardless of CMS’ actions, the offerors of the coupons are responsible for operating the program in compliance with federal law.


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