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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...
Navigating Texas Medicaid Formulary: Guide for Pharma Mfrs
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...
Medicare Phase-in: Qualifying 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...
2025 Medicare Part D Redesign: Impact on 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 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...
Best Practices for Vetting Marketed Pharma Drug Acquisitions
MASTERING BEST PRACTICES: Vetting Previously Marketed Pharmaceutical Drug AcquisitionsPharmaceutical manufacturers considering the acquisition of pre-existing drugs face the challenge of conducting a meticulous and comprehensive analysis across a spectrum of...
2024 Medicaid AMP Cap Removal: Pharma Manufacturer Impacts
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 Impacts Manufacturers
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...