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FDA Approvals
Genentech is pleased to announce the US Food and Drug Administration (FDA) approval of POLIVYĒį (polatuzumab vedotin-piiq) in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater.
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The Food and Drug Administration granted approval to epcoritamab-bysp (EPKINLY, Genmab) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B cell lymphoma, after two or more lines of systemic therapy.
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The Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.
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Coding and Reimbursement Updates
On May 1, the Center for Medicare & Medicaid Innovation (CMMI) updated its information and calculations relative to the forthcoming (July 1) Enhancing Oncology Model (EOM). This communication describes updates to the EOM payment methodology, specifically concerning the calculation of episode expenditures for performance period episodes.
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View the May E-Reimbursement Newsletter
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CMS & Noridian Updates
MolDX: Molecular Diagnostic Tests (MDT) (L35160) – R16 – Effective May 04, 2023
This Local Coverage Determination (LCD) has been revised under contractor numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, and NMI), and 01312 (NV).
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Top Denials and Solutions – Q2 Webinar – June 19, 2023
This event includes: Claim Denials, Electonic Data Interchange (EDI), Medical Necessity, Medicare Secondary Payer, Duplicate claims, Medical Review
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