Medicare Part D Inflation Rebates: January 9 Deadline Approaching As the January 9 deadline for Medicare Part D Inflation Rebates approaches, drug manufacturers are entering one of the most consequential compliance checkpoints introduced under the Inflation Reduction...
2026 CMS Final Rule: Expanded ASP Reporting and Verification Requirements for Manufacturers On November 5, 2025, CMS released the Calendar Year 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare...
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 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)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 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%....
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...
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...
Understanding the Medicare Phase-in: What It Means to Qualify as a Specified Manufacturer Do you have questions about the recent notice from CMS indicating that your company might qualify as a Specified Manufacturer for the Medicare Phase-In? Understanding this...