North America: Food, Drugs, Healthcare, Life Sciences

The U.S. Department of Justice recently secured a $32 million settlement with Dompé U.S. Inc. over allegations that the pharmaceutical company violated the Anti-Kickback Statute by paying Medicare beneficiaries' co-pays through patient assistance foundations to induce purchases of its drug Oxervate.

On October 1, the Health Resources and Services Administration (HRSA) published 10 approved rebate plans covering 18 Medicare-negotiated drugs, setting a January 1, 2027, start. As we warned in The 340B Squeeze (September 28), this is the first of three federal pricing changes that will land on a single outpatient claim. Health systems have about one quarter to get ready, and litigation could still change the picture.

As pharmacies enter the fourth quarter, we expect pharmacy benefit managers (PBMs) to intensify audit activity, pursue audit recoupments and increase efforts to suspend or terminate pharmacies from their networks. Pharmacy owners should prepare for heightened scrutiny of purchasing records, copayment collection, dispensing practices and compliance with provider agreements as the year closes. The potential consequences extend beyond repayment demands, as an adverse audit finding can threaten the pharmacy’s continued network participation and ability to serve its patients.