Category: Pharmaceuticals

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

Laura B. Morgan

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug discount and rebate arrangements that are commonplace between pharmaceutical manufacturers and Medicare Part D Plans and Medicaid Managed Care Organizations (and...

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

Nicole Burgmeier

In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May 2018, the Trump administration spoke on drug pricing and published its “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs”. One of...

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...