Putting Patients First Blog

JUNE 26, 2025

The NHC supports the efforts to reduce out-of-pocket costs for Medicare beneficiaries and appreciates CMS’ work to establish a process that seeks to incorporate patient perspectives into drug pricing policy. The IPAY 2028 guidance introduces a preliminary framework for addressing this evolution through potential renegotiation of MFPs.

Drug Pricing 52

Drug Pricing Communication Drug Development Documentation 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2.

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

Safe Biologics

MAY 10, 2024

View ASBM’s educational fact sheet “Interchangeability: US vs EU” here. Biden’s SOTU: 500 Drugs To Be Subject to Medicare Drug Price Controls On March 7th, President Biden gave his State of the Union address to Congress, wherein he laid out upcoming policy priorities for a potential second term.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130