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....
2023 DRUG WASTAGE RULE TO IMPACTPHARMA MANUFACTURERSPharmaceutical manufacturers continue to experience regulatory and program changes that result in new rebates and/or penalties which have the potential to negatively impact profitability. Last year, the Inflation...
MEDICAID REBATE LIABILITY FORECASTING AFTER UNWINDING, PUERTO RICO INCLUSIONFor pharmaceutical manufacturers accruing for Medicaid rebate liabilities, new updates on continuous enrollment unwinding from the COVID Public Health Emergency and the addition of Puerto Rico...
Update – Inflation Reduction Act Rebate Provisions for Pharma ManufacturersInflation Reduction Act – new updates! On August 16th, 2022, the Inflation Reduction Act (IRA) of 2022 was signed into law, creating potential impacts for drug manufacturers in the way of...