September 24, 2014—Pharmaceutical manufacturers’ current safeguards may not prevent all copayment coupons from being used for drugs paid for by Medicare Part D, the U.S. Health and Human Services Office of Inspector General says in a new report. [ms-protect-content id=”2799″]
In an accompanying special advisory bulletin, the OIG reminds drugmakers that they may be liable under the anti-kickback statute “if they offer coupons to induce the purchase of drugs paid for by Federal health care programs, including Medicare Part D.”
Drug manufacturers have been increasingly relying on copay coupons to bolster sales and sustain market share. In its report, the OIG observed that “the use of coupons by Medicare beneficiaries could impose significant costs on the Part D program because many coupons encourage beneficiaries to choose more expensive brand-name drugs over less expensive alternative drugs.”
To identify and evaluate manufacturers’ safeguards, the OIG surveyed 30 manufacturers of the top 100 Part D brand-name drugs with coupons and with the highest Medicare expenditures. It also reviewed selected safeguards offered for a sample of those drugs.
“Most surveyed manufacturers use pharmacy claims edits to prevent coupons from being processed for drugs covered by Part D,” the OIG found. “Most of these edits may not prevent all coupons from being processed for Part D-covered drugs.”
The OIG said its advisory bulletin “affirms that pharmaceutical manufacturers are at risk of sanctions if they fail to take appropriate steps to ensure that their copayment coupons do not induce the purchase of Federal health care programs items or services, including but not limited to, drugs paid for by Medicare Part D.”
“For this reason, manufacturers may engage industry stakeholders and the Centers for Medicare & Medicaid Services in an effort to identify a solution to ensure that coupons are not used for drugs paid for by Part D,” it said. [/ms-protect-content]