FDA Approval: CEFEPIME (CEFEPIME) — Type 3 - New Dosage Form
Policy FDA-NDA050817 • Infectious Disease
CriticalBaxter 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
FDA Approval: ZEVTERA (CEFTOBIPROLE MEDOCARIL SODIUM) — Type 1 - New Molecular Entity
Policy FDA-NDA218275 • Infectious Disease
CriticalZevtera (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
FDA Approval: REXTOVY (NALOXONE HYDROCHLORIDE) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA208969 • Infectious Disease
HighREXTOVY (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
FDA Approval: LINEZOLID (LINEZOLID) — Type 3 - New Dosage Form
Policy FDA-NDA021132 • Infectious Disease
HighLinezolid for suspension is an oral medication that will be billed under Medicare Part D. Since it does not have an injectable form, there will be no assignment of J-codes. Billing teams should monito
FDA Approval: ZYVOX (LINEZOLID) — Type 3 - New Dosage Form
Policy FDA-NDA021131 • Infectious Disease
HighZYVOX (Linezolid) is an injectable drug likely to receive a J-code assignment for billing. It will be billed under Part B, and potential ASP+6% payment may apply due to its injectable nature.
FDA Approval: ZYVOX (LINEZOLID) — Type 1 - New Molecular Entity
Policy FDA-NDA021130 • Infectious Disease
HighZYVOX (Linezolid) is an oral antibacterial drug that falls under Medicare Part D for billing. Since it is not an injectable, a J-code assignment is not applicable. No pass-through payment or ASP+6% wi
FDA Approval: LINEZOLID (LINEZOLID) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA206473 • Infectious Disease
HighThe 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 wil
FDA Approval: VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) — Type 3 - New Dosage Form
Policy FDA-NDA050671 • Infectious Disease
HighWith the approval of Vancomycin Hydrochloride as an injectable solution, it is likely to be assigned a J-code for Medicare billing. The reimbursement may follow the ASP+6% model due to its injectable
FDA Approval: MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) — Type 4 - New Combination
Policy FDA-NDA021078 • Infectious Disease
HighAs a newly approved oral drug, Malarone will be billed under Medicare Part D. Since it is a combination therapy for malaria, billing teams should note potential variations in coverage and reimbursemen
LCD L38988: MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing — Palmetto GBA
Policy LCD-L38988 • Infectious Disease / Microbiology
HighThe new LCD for Molecular Syndromic Panels will streamline the billing process for pathogen identification testing by establishing clear guidelines. This could potentially supports compliance with updated rates for facilit
LCD L38331: MolDX: Blood Product Molecular Antigen Typing — Noridian
Policy LCD-L38331 • Infectious Disease / Microbiology
HighThe Noridian LCD for Blood Product Molecular Antigen Typing effective from January 22, 2026, could substantially impact reimbursement for labs specializing in this testing. Labs should prepare for upd
LCD L38333: MolDX: Blood Product Molecular Antigen Typing — Noridian
Policy LCD-L38333 • Infectious Disease / Microbiology
HighThe effective date of the new MolDX guidelines for Blood Product Molecular Antigen Typing will shift billing requirements, potentially impacting reimbursement for impacted services. Providers should p
LCD L39001: MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing — Noridian
Policy LCD-L39001 • Infectious Disease / Microbiology
HighThe implementation of this LCD on molecular syndromic panels will significantly influence billing practices for infectious disease testing. Providers will need to ensure they comply with the outlined
LCD L39003: MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing — Noridian
Policy LCD-L39003 • Infectious Disease / Microbiology
HighThe new LCD regarding MolDX: Molecular Syndromic Panels for Infectious Disease may impact billing practices significantly for laboratories involved in pathogen identification testing. Providers should
LCD L39226: Multiplex Gastrointestinal Pathogen Panel (GPP) Tests for Acute Gastroenteritis (AGE) — NGS
Policy LCD-L39226 • Infectious Disease / Microbiology
HighThe new LCD for Multiplex Gastrointestinal Pathogen Panel tests addresses billing guidelines for acute gastroenteritis. It is crucial for providers to understand the changes in coverage and documentat
LCD L38249: MolDX: Blood Product Molecular Antigen Typing — CGS
Policy LCD-L38249 • Infectious Disease / Microbiology
HighThe new MolDX for Blood Product Molecular Antigen Typing will likely lead to changes in billing protocols, impacting how blood products are reimbursed under Medicare. Providers must familiarize themse
LCD L39038: MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing — CGS
Policy LCD-L39038 • Infectious Disease / Microbiology
HighThe implementation of MolDX for molecular syndromic panels may significantly enhance pathogen identification capabilities for infectious diseases. This change will likely impact claims processing and