Infectious Disease reimbursement alerts

Sunlenca (lenacapavir sodium) was approved as an oral tablet for HIV treatment, placing it squarely in the Medicare Part D billing pathway as a self-administered drug. As an oral tablet, it does not q

Sunlenca (lenacapavir sodium) was approved as a subcutaneous solution for HIV treatment, supporting a Part B billing pathway consistent with its injectable route of administration. As a new molecular

BIXLENVO (bictegravir/lenacapavir), an oral tablet combination antiretroviral approved by FDA on August 27, 2026, follows a Part D billing pathway consistent with its oral route of administration. As

This is a 2015 Type 5 approval of an intravenous cefazolin sodium solution by Baxter Healthcare Corporation, representing a new formulation or manufacturer rather than a novel molecular entity. As an

Oxacillin sodium injection (NDA050640) is an injectable antibiotic administered via the intravenous or intramuscular route, supporting a Medicare Part B billing pathway for hospital outpatient and phy

Tivicay PD (dolutegravir sodium) is an oral tablet for suspension approved as a new dosage form of the existing HIV integrase inhibitor dolutegravir, indicated for pediatric patients. As an oral formu

Tivicay (dolutegravir sodium) is an oral tablet approved for HIV treatment, billing under Medicare Part D as a self-administered medication. As an oral drug, it does not qualify for Part B physician-a

Baraclude (entecavir) is an oral tablet approved for hepatitis B, billing through Medicare Part D as a self-administered oral medication. As an oral drug, it does not qualify for Part B physician-admi

This approval is a new intravenous formulation of vancomycin (NDA211962) by Xellia Pharmaceuticals USA LLC, a well-established glycopeptide antibacterial with an existing HCPCS coding framework. As an

This approval represents a new formulation/manufacturer submission (Type 5) for meropenem, an established intravenous carbapenem antibiotic, by WG Critical Care, LLC. Given the intravenous route of ad

Veklury (remdesivir) is an intravenous SARS-CoV-2 antiviral approved for COVID-19, administered in hospital or clinical settings via IV infusion, placing it squarely in the Medicare Part B billing pat

Kaletra (lopinavir/ritonavir) is an oral tablet combination protease inhibitor approved for HIV treatment, billing under Medicare Part D as a self-administered oral medication. This 2005 new dosage fo

Norvir (ritonavir) powder, approved as a new oral dosage form under NDA209512, follows a Part D billing pathway as an oral medication dispensed through retail or specialty pharmacy. This orphan drug a

Norvir (ritonavir) tablets received FDA approval as a new oral dosage form under NDA022417, with a clear Part D billing pathway consistent with its oral route of administration. As a CYP3A inhibitor p

Brexafemme (ibrexafungerp citrate) is an oral tablet approved for vulvovaginal candidiasis, billing through Medicare Part D as a self-administered drug. Because it is an oral tablet dispensed at the p

This active final LCD from Wellpoint Federal establishes coverage criteria for Respiratory Pathogen Panel Testing under Part B, effective April 1, 2026. It defines the clinical indications, documentat

Rezzayo (rezafungin) is an intravenous echinocandin antifungal approved as a new molecular entity, placing it squarely in the Medicare Part B pathway as a provider-administered drug. As a newly approv

Augmentin '125' (Amoxicillin) is an oral chewable tablet approved under NDA050597, following a Part D billing pathway as a retail pharmacy dispensed antibiotic. As an established oral combination anti

This oral suspension formulation of amoxicillin/clavulanate potassium follows the Part D billing pathway, consistent with its oral route of administration. As a long-established generic antibiotic com

Augmentin '200' (amoxicillin/clavulanate) is an oral chewable tablet approved in 1996 under NDA050726, following the Part D billing pathway as a retail pharmacy drug. As an oral antibiotic with long-e

Amoxicillin/clavulanate potassium (extended-release tablet) is an oral antibiotic approved under a new dosage form submission, billing through Medicare Part D as a retail pharmacy benefit. This is a w

Augmentin ES-600 is an oral amoxicillin/clavulanate potassium suspension approved as a new dosage form, billing under Medicare Part D as a self-administered oral antibiotic. As a generic-class oral an

Amoxicillin and clavulanate potassium (oral tablet) is a well-established combination antibiotic approved under a new dosage form submission, billing through Medicare Part D as an oral outpatient pres

Augmentin '400' (amoxicillin/clavulanate) is an oral suspension formulation approved under NDA050725 as a new dosage form, billing through Medicare Part D as a retail pharmacy drug. As an oral antibio

Serostim (somatropin) is an injectable growth hormone approved for HIV-associated wasting, billed under Medicare Part B given its injectable route of administration and physician-administered context.

Zithromax (azithromycin dihydrate) oral tablets were approved under NDA050711 as a new dosage form, billing through Medicare Part D as a self-administered oral medication. As a well-established generi

Zithromax (azithromycin dihydrate) oral suspension is an established oral antibiotic approved under NDA050710, billing through Medicare Part D as a self-administered medication. As a long-genericized,

Zithromax (azithromycin) is an oral capsule antibiotic approved under Part D, meaning it is dispensed through retail or mail-order pharmacies and billed to Medicare prescription drug plans rather than

This 2002 approval of an oral azithromycin tablet formulation (Zithromax) follows the Part D billing pathway, consistent with its oral route of administration. As a long-established generic antibiotic

Zithromax (azithromycin dihydrate) was approved as an injectable dosage form via NDA050733, administered by injection and billed under Medicare Part B. As an established antibiotic with a known inject

Azithromycin (Zithromax) in oral tablet form follows a Part D billing pathway, consistent with its outpatient, self-administered route of administration. As an oral antibiotic with long-established ge

Sporanox (itraconazole) oral solution received FDA approval as a new dosage form under NDA020657, adding a liquid formulation to the existing capsule product. As an oral antifungal, this drug follows

Sporanox (itraconazole) is an oral capsule antifungal that follows a Part D billing pathway, as it is a self-administered medication dispensed through retail or specialty pharmacy. As an established o

Fetroja (cefiderocol) is an intravenous powder antibiotic approved for gram-negative bacterial infections, administered via IV infusion, which places it squarely in the Medicare Part B billing pathway

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

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

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

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

Linezolid 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

ZYVOX (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.

ZYVOX (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

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 wil

With 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

As 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

The 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

The 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

The 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

The 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

The new LCD regarding MolDX: Molecular Syndromic Panels for Infectious Disease may impact billing practices significantly for laboratories involved in pathogen identification testing. Providers should

The 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