Tagged: Safe Harbor

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...

OIG Seeks Public Input on Anti-Kickback Statute and Beneficiary Inducements CMP as part of the “Regulatory Sprint to Coordinated Care”

Laura B. Morgan

The Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) has identified the anti-kickback statute (AKS) and beneficiary inducements civil monetary penalty (CMP) as potential barriers to arrangements that could promote better patient care coordination and value-based arrangements.  On August 27, 2018, the OIG published a Request for Information (RFI) seeking input...

FDA Chief and HHS Secretary Cite Prescription Drug Prices as Top Priorities for Agencies; President Trump Scheduled to Speak on Issue on May 11, 2018.

Nicole Burgmeier

All eyes are on the federal government as top officials have recently signaled upcoming actions which could impact the prices of prescription drugs. In the past two weeks, leaders from both the FDA and HHS have made statements signaling that the agencies are focused on reducing prescription drug prices. In remarks at the Food and...