Michael McCaughan is a founding member of Prevision Policy LLC, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. He was previously the Editor-In-Chief of The Pink Sheet and remains a contributor to the publication.
Latest from Michael McCaughan
CMS backs off on a plan to put “guardrails” around manufacturer payments that are excluded from Average Sales Price calculations in Medicare, but is planning to revisit the issue.
The final guidance for the upcoming third round of the Medicare drug price negotiation process is most notable for the amount left unchanged.
FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad and Commissioner Martin Makary get along?
The FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad, and Commissioner Martin Makary get along?
The US FDA’s Oncology Center of Excellence is eager to work with osteosarcoma researchers to advance trials for the difficult to study cancer – but OCE officials made clear that they are not likely to use mandatory pediatric study authorities to force the issue.
The Trump Administration’s formula for ‘Most Favored Nation’ pharmaceutical pricing has evolved since the first Trump team proposed MFN pricing for Medicare in 2020. The ‘GENEROUS’ Medicaid model in 2025 is indeed more generous to manufacturers – though still not an attractive proposition.