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Baseline AMP: Essential Guide to Compliance and Maximizing 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: What Pharma Manufacturers Need to Know
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...
Understanding Prescription Drug Line Extensions: Key Insights on URA, Medicaid Rebates, and 340B Program Impact
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 Change: A Deep Dive into the Pending CMS Rule (CMS-2434) for Pharma 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...
Navigating the Texas Medicaid Formulary: A Comprehensive Guide for Pharmaceutical Manufacturers
NAVIGATING THE TEXAS MEDICAID FORMULARY: A Comprehensive Guide for Pharmaceutical ManufacturersThe landscape of pharmaceutical product listing in Texas presents unique challenges for manufacturers seeking Medicaid coverage. Unlike other states, Texas operates its own...
Understanding the Medicare Phase-in: What It Means to Qualify as a Specified Manufacturer
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
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
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...