Earlier this week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled, Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs (Report). Copayment coupons are offered by pharmaceutical manufacturers in many forms, including print coupons, electronic coupons, debit cards and direct reimbursements, in order to reduce or eliminate a consumer’s immediate out-of-pocket costs for a specific pharmaceutical product. Because these “coupons constitute remuneration offered to consumers to induce the purchase of specific items”, the federal Anti-Kickback Statute may be implicated. The Report and Bulletin state that, while many manufacturers have measures in place to prevent the use of coupons when a pharmaceutical product will be paid for by a federal health care program (FHCP), the OIG has determined that current safeguards may not be sufficient.
The Report calls on pharmaceutical companies and CMS to identify a solution to prevent coupons from being used to purchase pharmaceuticals paid for by a FHCP. Nevertheless, pharmaceutical manufacturers are reminded that they “ultimately bear the responsibility to operate these programs in compliance with Federal law” and “may be subject to sanctions if they fail to take appropriate steps to ensure that such coupons do not induce the purchase of [FHCP] items or services, including, but not limited to, drugs paid for by Medicare Part D. Failure to take such steps may be evidence of intent to induce the purchase of drugs paid for by these programs, in violation of the anti-kickback statute.”
Pharmaceutical manufacturers that use, or are considering using, copayment coupons should carefully review the OIG Report and Bulletin to determine whether additional safeguards should be implemented. Pharmaceutical manufacturers also should consider ways to engage with CMS to identify a workable solution.