SpecGx, a generic subsidiary of Mallinckrodt Pharmaceuticals, will refund 340B covered entities that purchased addiction treatment medication Methadose for above [...] …
Category: Regulatory
The Department of Health and Human Services (HHS) has submitted proposed 340B rebate guidance for regulatory review—but it is unclear [...] …
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Breaking News
Trump’s Full 2026 Budget Request Would Shift 340B Program from HRSA to CMS, Maintain Current OPA Funding
President Donald Trump’s fiscal year 2026 budget request released yesterday calls for moving control of the 340B program away from [...] …
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The first published decision under the revamped 340B Administrative Dispute Resolution (ADR) process sided with the drug industry, marking a [...] …
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Three drugmakers will refund covered entities that purchased certain 340B-priced medications following recent adjustments to their 340B drug ceiling prices. [...] …
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The Trump administration this month urged a Washington D.C. federal court to uphold a 2013 Health Resources and Services Administration [...] …
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A federal judge’s decision to uphold the government’s authority to pre-approve drugmaker 340B rebate models has drawn praise from providers, [...] …
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Three drugmakers recently announced refunds for 340B covered entities that were overcharged when buying certain drugs. Viatris, Amgen and GSK [...] …
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Breaking News
Federal Judge Upholds HHS’ Right to Pre-Approve 340B Rebates, Tosses Four of Five Drugmaker Lawsuits
A federal district judge has upheld the federal government’s authority to require agency approval of drugmaker 340B rebate models, dealing [...] …
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Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. provided his first public remarks on the 340B program Wednesday [...] …