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...
Overview of the 2025 Medicare Part D Program Redesign: A Paradigm Shift for Pharma Manufacturers The Medicare Modernization Act of 2003 included the Coverage Gap or Donut Hole, as it’s commonly referred to, as a part of the redesign of the Part D drug benefit. This...
Navigating the Changing Landscape of Pharmaceutical State Price Transparency Reporting In the world of pharmaceutical manufacturing, staying up to date on regulatory changes and market dynamics is essential for success. Recently, there has been a significant shift...
2024 AMP CAP REMOVAL What You Need To Know2024 AMP CAP REMOVAL – WHAT PHARMA MANUFACTURERS NEED TO KNOWThe 2024 Medicaid AMP cap removal will be effective January 1st, 2024, and may have sweeping impacts for drug manufacturers participating in the Medicaid program....