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...
CMS Enforcement of Average Sales Price (ASP) Submissions for all Medicare Part B Eligible Pharmaceuticals and BiopharmaceuticalsRecently, CMS has been sending letters to pharma and biopharma manufacturers (with and without MDRP agreements) indicating that they believe...
Update – 2023 Best Price & Accumulator Adjustment Program Ruling2023 was shaping up to be a year of challenging decisions for manufacturers and restricted access to critical pharmaceuticals for patients. The 2023 implementation of the proposed CMS Medicaid Best...
Inflation Reduction Act Likely to Have a Negative Financial Impact On Many Drug ManufacturersOn August 16, 2022, the Inflation Reduction Act of 2022 was signed into law with provisions aimed at lowering drug, health care and energy costs for consumers in the United...