Category: Pharmaceuticals

Drug Rebates Threatened Under Proposed Anti-kickback Rule

Benjamin Fee

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical manufacturers pay to Medicare and Medicaid plan sponsors and their pharmacy benefit managers (“PBMs”). The OIG proposed replacing the current safe harbor...

Getting Ready for Open Payments

Kristen Barlow

Today, the Centers for Medicare and Medicaid Services (“CMS”) released additional tips regarding submitting Open Payments data.[1] A quick refresher: Submitting data through CMS’s application, Open Payments, is the means to fulfill the Sunshine Act, a federal regulatory requirement that applicable manufacturers, group purchasing organizations (“GPOs”), and health care providers disclose: a) certain transfers of...