DSCSA Implementation is Driving New State Licensing Requirements for Drug Manufacturers As implementation of the Drug Supply Chain Security Act (DSCSA) continues, pharmaceutical manufacturers are seeing related changes extend into state manufacturer licensing...
VA Labeler Code Enforcement: Why Pharmaceutical Manufacturers Should Prepare Now If your pharmaceutical company relies on a third-party dealer to access the U.S. Department of Veterans Affairs (VA) market, recent activity from the VA Federal Supply Schedule (FSS)...
U.S. Pharmaceutical Tariffs Expand to Generic Drugs: What Manufacturers Need to Know When Prescription Analytics first examined pharmaceutical tariff policy in 2025, no pharma-specific framework had been finalized. Since then, the policy has advanced, with a branded...
CMS Confirms Q2 2026 ASP Reporting Requirements for Reasonable Assumptions and BFSF Documentation CMS has provided updated guidance on the new Average Sales Price (ASP) reporting requirements related to reasonable assumptions and, where applicable, bona fide service...
VA Federal Supply Schedule Contract Terms May Extend to 20 Years For pharmaceutical manufacturers with VA Federal Supply Schedule (FSS) agreements, the Department of Veterans Affairs (VA) recently announced a structural change that could affect long-term planning,...
CMS Delays New Q1 2026 ASP Reporting Requirements CMS has announced that the new ASP reporting requirements tied to bona fide service fee certifications and reasonable assumptions will be waived for the first sales quarter of 2026 due to implementation delays. As a...
What the 12-Digit NDC Means for Government Pricing, Rebates, and Reporting The FDA recently finalized a rule transitioning National Drug Codes (NDCs) from the current 10 and 11 digit formats to a standardized 12-digit NDC structure (6-4-2). Implementation begins March...
CMS 2026 ASP Reporting Update: Reasonable Assumptions Form Due April 30 Under the 2026 CMS Final Rule, pharmaceutical manufacturers face a new compliance requirement: beginning with Q1 2026 ASP reporting, manufacturers must submit a Reasonable Assumptions Form...
Congress Just Drew a Line on PBM Compensation Recently, President Trump signed the Consolidated Appropriations Act of 2026, avoiding a government shutdown and setting federal funding for the year. Included inside the bill is a major policy change that will reshape how...