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Pharma Executives’ Guide to 2025: U.S. Drug Tariffs, TrumpRx, and Manufacturing Shifts
Pharma Executives’ Guide to 2025: U.S. Drug Tariffs, TrumpRx, and Manufacturing ShiftsThe Trump administration’s latest policy signals could mark a significant change for the pharmaceutical sector - combining the threat of sweeping tariffs on branded drugs with the...
2026 CMS Proposed Rule: BFSF Clarifications & Compliance Risks for Pharma Manufacturers
2026 CMS Proposed Rule: BFSF Clarifications & Compliance Risks for Pharma Manufacturers On July 16, 2025, CMS released the CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings...
What Pharma Manufacturers Need to Know About the New “One Big Beautiful Bill Act” (OBBBA)
What Pharma Manufacturers Need to Know About the New “One Big Beautiful Bill Act” (OBBBA)Key Takeaways from the Latest Regulatory Reforms Impacting Medicaid, Medicare, and Drug Pricing On July 4, 2025, the "One Big Beautiful Bill Act" (OBBBA) was signed into law,...
Emerging U.S. Tariff Policy and Its Potential Impact on Pharma Manufacturers
Emerging U.S. Tariff Policy and Its Potential Impact on Pharma ManufacturersOverview Recent comments by President Trump have introduced new uncertainty into the pharmaceutical sector, with strong suggestions that imported drugs could face tariffs as high as 200%....
Baseline AMP: Guide to Compliance & Profitability
For pharmaceutical manufacturers, a comprehensive understanding of the Baseline Average Manufacturer Price (AMP) is crucial. Its establishment and calculation significantly impact profitability, compliance and long-term value of your product. In this white paper,...
CMS Final Rule: Key Takeaways for Pharma Manufacturers
CMS Final Rule: What Pharma Manufacturers Need to Know On September 26, 2024, the Centers for Medicare & Medicaid Services (CMS) published its Final Rule, introducing important changes for pharmaceutical manufacturers participating in the Medicaid Drug Rebate...
Why are My Medicaid Rebates So High?
Have you found yourself asking, "Why are my Medicaid rebates so high?" You're not alone. Many of our clients pose this very question. To help you understand and manage your Medicaid rebate liability, we examine three critical areas. This white paper will guide you...
Prescription Drug Line Extensions: URA, Rebates & 340B
For pharmaceutical manufacturers acquiring or launching brand drugs, line extensions remain a topic fraught with frequent inquiries and complexities. Line extensions, with their unique formulas to determine the Unit Rebate Amount (URA), can often be a source of...
Navigating the Pending CMS-2434 Rule for Manufacturers
Navigating Change: A Deep Dive into the Pending CMS Rule (CMS-2434) for Pharma Manufacturers The CMS Final Rule currently pending holds significant implications for pharmaceutical manufacturers. Within the Office of Information and Regulatory Affairs (OIRA), there are...