FDA Approval: USTEKINUMAB (USTEKINUMAB) — Type 3 - New Dosage Form
Policy FDA-BLA761044 • Rheumatology
CriticalUstekinumab (BLA 761044), approved by Janssen Biotech as a new injectable dosage form, follows the Part B billing pathway given its injectable route of administration. As an established biologic inter
FDA Approval: BENLYSTA (BELIMUMAB) — Type 1 - New Molecular Entity
Policy FDA-BLA125370 • Rheumatology
HighBenlysta (belimumab) is an injectable B Lymphocyte Stimulator-specific Inhibitor approved for systemic lupus erythematosus, administered via injection and billed under Medicare Part B. As a physician-
FDA Approval: BENLYSTA (BELIMUMAB) — Type 3 - New Dosage Form
Policy FDA-BLA761043 • Rheumatology
HighBenlysta (belimumab) received approval for a new injectable dosage form under BLA761043, expanding on its existing intravenous formulation with a subcutaneous injection route that supports Part B bill
FDA Approval: YESINTEK (USTEKINUMAB) — Type 2 - New Active Ingredient
Policy FDA-BLA761406 • Rheumatology
HighYESINTEK (ustekinumab) is a biosimilar to Stelara, approved as an injectable administered by injection, placing it on the Medicare Part B billing pathway. As a biosimilar, it will likely be reimbursed
FDA Approval: SAPHNELO (ANIFROLUMAB-FNIA) — Type 1 - New Molecular Entity
Policy FDA-BLA761123 • Rheumatology
HighSaphnelo (anifrolumab-fnia) is an injectable Type I Interferon Receptor Antagonist approved for systemic lupus erythematosus, administered via intravenous infusion and billed under Medicare Part B. As
FDA Approval: KRYSTEXXA (PEGLOTICASE) — Type 1 - New Molecular Entity
Policy FDA-BLA125293 • Rheumatology
HighKrystexxa (pegloticase) is an injectable, PEGylated uricase approved for chronic refractory gout and administered via intravenous infusion, placing it firmly in the Medicare Part B billing pathway und
FDA Approval: TRUTAKNA (atacicept-vymj) — Type 1 - New Molecular Entity
Policy FDA-BLA761486 • Rheumatology
HighTRUTAKNA (atacicept-vymj) received FDA approval on July 7, 2026 as a subcutaneous injectable, which supports a Part B billing pathway for physician-administered drugs. As a new molecular entity withou
FDA Approval: XELJANZ (TOFACITINIB) — Type 1 - New Molecular Entity
Policy FDA-NDA203214 • Rheumatology
RoutineXeljanz (tofacitinib) is an oral tablet approved under NDA203214, placing it squarely in the Medicare Part D billing pathway as a self-administered drug. Because it is dispensed via retail or specialt
FDA Approval: XELJANZ XR (TOFACITINIB) — Type 3 - New Dosage Form
Policy FDA-NDA208246 • Rheumatology
RoutineXeljanz XR (tofacitinib) is an oral extended-release tablet approved as a new dosage form of the already-marketed Xeljanz, placing it squarely in the Medicare Part D billing pathway. As an oral self-a
FDA Approval: RINVOQ (UPADACITINIB) — Type 1 - New Molecular Entity
Policy FDA-NDA211675 • Rheumatology
RoutineRinvoq (upadacitinib) is an oral extended-release tablet approved as a new molecular entity, placing it squarely in the Medicare Part D billing pathway rather than Part B. As a self-administered oral
FDA Approval: XELJANZ (TOFACITINIB) — Type 3 - New Dosage Form
Policy FDA-NDA213082 • Rheumatology
RoutineXeljanz (tofacitinib) oral solution received FDA approval as a new dosage form under NDA213082, expanding on the existing tablet formulations already on the market. As an oral drug, this approval foll
FDA Approval: OLUMIANT (BARICITINIB) — Type 1 - New Molecular Entity
Policy FDA-NDA207924 • Rheumatology
RoutineOlumiant (baricitinib) is an oral Janus Kinase (JAK) inhibitor approved as a new molecular entity, billing under Medicare Part D as a self-administered tablet. As an oral outpatient medication, it doe
FDA Approval: RINVOQ (UPADACITINIB) — Type 3 - New Dosage Form
Policy FDA-NDA218347 • Rheumatology
RoutineThis approval represents a new oral solution dosage form of upadacitinib (RINVOQ), a Janus Kinase Inhibitor, under NDA218347. As an oral formulation, this drug follows the Part D billing pathway, cons
FDA Approval: EXDENSUR (DEPEMOKIMAB) — Type 1 - New Molecular Entity
Policy FDA-BLA761458 • Rheumatology
HighThis newly approved drug, EXDENSUR (Depemokimab), has a confirmed route of administration as subcutaneous injection, allowing billing teams to categorize it under Part B. As it aligns with injectable
LCD L39427: MolDX: Molecular Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis — CGS
Policy LCD-L39427 • Rheumatology
HighThe MolDX policy for molecular biomarker testing could significantly impact reimbursement for targeted therapy selection in Rheumatoid Arthritis. As this policy becomes effective, providers may need t
LCD L39481: MolDX: Molecular Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis — WPS
Policy LCD-L39481 • Rheumatology
HighThe implementation of the MolDX guidelines for molecular biomarker testing in rheumatoid arthritis could significantly affect billing processes related to targeted therapy. Providers will need to ensu
LCD L39467: MolDX: Molecular Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis — Noridian
Policy LCD-L39467 • Rheumatology
HighThe new LCD for Molecular Biomarker Testing in Rheumatoid Arthritis may expand the coverage for specific biomarkers, improving the choice of targeted therapies. This change will allow practices to bil
LCD L39469: MolDX: Molecular Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis — Noridian
Policy LCD-L39469 • Rheumatology
HighThe implementation of the MolDX guidelines for molecular biomarker testing in rheumatoid arthritis will ensure more precise targeting of therapies and could enhance treatment outcomes. As these guidel