FDA-NDA206473
Document details
Summary
The new formulation of Linezolid, administered intravenously, is likely to be assigned a J-code for Medicare billing. As an injectable Part B drug, it may also qualify for pass-through payment and wilNew Linezolid formulation could impact Medicare billing.
Affected specialty
Infectious Disease alerts →Source document
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206473s000lbl.pdfCLV Intelligence summarizes publicly available federal publications. Not affiliated with or endorsed by any government agency.
Related alerts
4Policy FDA-NDA050817 · Infectious Disease
Baxter Healthcare's new dosage form of cefepime (injectable, NDA050817) follows the Part B billing pathway, consistent with its intravenous/injection route of administration typically administered in
View alertPolicy FDA-NDA218275 · Infectious Disease
Zevtera (ceftobiprole medocaril sodium) is an intravenous antibiotic approved via NDA218275, administered as a reconstituted powder for IV infusion, placing it squarely in the Medicare Part B billing
View alertPolicy LCD-L39044 · Clinical Laboratory
The LCD L39044 focuses on coverage for molecular syndromic panels for infectious disease pathogen identification. As a final LCD, it is currently active and will be effective starting June 25, 2026, i
View alertPolicy FDA-NDA208969 · Infectious Disease
REXTOVY (naloxone hydrochloride), a nasal spray, will likely fall under Medicare Part D for oral drugs, as it is not injectable and thus not eligible for Part B billing. Billing teams should consider
View alert