Oncology reimbursement alerts

Rasonque (daraxonrasib) is an oral tablet approved as a new molecular entity under Priority Review with Orphan Drug designation, placing it squarely in the Medicare Part D billing pathway. As an oral

VOBRIG (leuprolide acetate) is a new injectable formulation of an established GnRH agonist, approved under NDA213225 as a Type 5 submission by Sun Pharmaceutical Industries Limited. As an injectable a

Cemiplimab-rwlc (Libtayo) is an intravenous injectable PD-1 inhibitor approved for oncology indications, billing under Medicare Part B as a provider-administered drug. It is reimbursed at ASP+6% under

Bavencio (avelumab), a PD-L1 checkpoint inhibitor administered by injection, follows a Part B billing pathway as a provider-administered injectable oncology drug. It is reimbursed under the Medicare P

Unloxcyt (cosibelimab), a PD-L1 checkpoint inhibitor approved December 2024, is administered by injection and follows a Part B billing pathway, reimbursed under the physician/outpatient setting at ASP

Imjudo (tremelimumab), a CTLA-4-directed blocking antibody administered intravenously, follows a Part B billing pathway as a physician-administered injectable. As a newly approved biologic (BLA 761289

Penpulimab (PENPULIMAB KCQX), a newly approved intravenous injectable oncology biologic (BLA761258) with orphan drug designation, will be billed under Medicare Part B as a provider-administered drug.

Loqtorzi (toripalimab-tpzi), a PD-1 blocking antibody approved for nasopharyngeal carcinoma, is administered via injection and follows a Part B billing pathway, consistent with physician-administered

Tevimbra (tislelizumab-jsgr) is an intravenous PD-1 blocking antibody approved under BLA 761232, placing it squarely in the Medicare Part B billing pathway as a physician-administered drug. As a new m

Ziihera (zanidatamab-hrii), a bispecific HER2-directed antibody approved November 2024 for an orphan indication, is administered via injection and billed under Medicare Part B. As a newly approved bio

This proposed LCD from Noridian establishes coverage criteria for next-generation sequencing (NGS) in hematologic malignancies and suspected hematologic malignancies across 15 western states under Par

This proposed LCD from Noridian would establish coverage criteria for transcriptional biomarker tests used in therapeutic decision-making for renal carcinoma patients across 15 western and mountain st

This proposed LCD from Noridian covers genome-wide molecular testing (e.g., chromosomal microarray, optical genome mapping) for detecting copy number alterations and structural variants in hematologic

This proposed LCD from CGS (J15) addresses coverage criteria for genome-wide molecular methodologies detecting copy number alterations and structural variants in hematologic neoplasms across Kentucky

This proposed LCD from CGS (J15) addresses coverage of transcriptional biomarkers used for therapeutic decision-making in renal carcinoma, applicable to Part A and Part B in Kentucky and Ohio. As a dr

This proposed LCD from CGS (J15) addresses coverage criteria for next-generation sequencing (NGS) used in diagnosing and managing hematologic malignancies in Kentucky and Ohio under both Part A and Pa

This proposed LCD from Palmetto GBA addresses coverage criteria for genome-wide molecular testing methods detecting copy number alterations and structural variants in hematologic neoplasms. As a draft

This proposed LCD from Palmetto GBA (MolDX) addresses coverage criteria for transcriptional biomarker testing used in therapeutic decision-making for renal carcinoma. As a draft policy, it has not yet

Palmetto GBA has released a proposed LCD (DL40425) establishing coverage criteria for next-generation sequencing (NGS) panels used in diagnosing and managing hematologic malignancies under the MolDX p

This final LCD from CGS (J15) establishes coverage criteria for non-next generation sequencing targeted molecular panel tests used to guide targeted therapy decisions in cancer patients in Kentucky an

This final LCD from WPS (J5/J8) establishes coverage criteria for non-next generation sequencing targeted molecular panel tests used to guide targeted therapy decisions in cancer patients, effective O

This final LCD from Palmetto GBA (L40210) establishes coverage criteria for non-next generation sequencing targeted molecular panel tests used for targeted therapy decisions in cancer, effective Octob

Vemurafenib (Zelboraf) is an oral kinase inhibitor approved for BRAF V600E mutation-positive melanoma, billing under Medicare Part D as an oral tablet. As an oral oncology drug, it does not qualify fo

Cotellic (cobimetinib) is an oral tablet approved under NDA206192, placing it squarely in the Medicare Part D billing pathway as a self-administered drug. As an oral oncology agent with orphan drug de

Nivolumab (Opdivo) is an injectable PD-1 blocking antibody administered via intravenous infusion, placing it squarely in the Medicare Part B billing pathway as a physician-administered drug. As a new

Neulasta (pegfilgrastim) is administered subcutaneously and follows a Part B billing pathway, typically covered when administered incident-to a physician visit or via the Onpro on-body injector in a c

Hernexeos (zongertinib) is an oral tablet kinase inhibitor approved under NDA219042, billing through Medicare Part D as a self-administered outpatient drug. As an oral oncology agent, it falls under P

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is an intravenous radioligand therapeutic approved for metastatic castration-resistant prostate cancer, placing it firmly in the Part B billing pathway

JIDEYTRO (zidesamtinib), approved July 22, 2026 as a new oral tablet NDA, is an orphan drug that will route through Medicare Part D for outpatient prescription coverage. As an oral tablet, it does not

Xtandi (enzalutamide) is an oral capsule approved for prostate cancer, placing it squarely in the Medicare Part D billing pathway as a self-administered outpatient drug. As an oral androgen receptor i

This approval represents a new tablet dosage form of enzalutamide (Xtandi), an oral androgen receptor inhibitor used in prostate cancer. As an oral outpatient drug, Xtandi tablets are covered under Me

CAMCEVI ETM (leuprolide mesylate) was approved as a subcutaneous emulsion formulation under NDA219745, representing a new formulation of an existing active ingredient. Given its subcutaneous route of

This final LCD from Wellpoint Federal governs Medicare coverage for allogeneic hematopoietic cell transplantation (allo-HCT) in patients with primary refractory or relapsed Hodgkin and Non-Hodgkin Lym

Neupogen (filgrastim) is administered intravenously and falls under Medicare Part B, typically billed in physician office or outpatient settings where it is administered. It has established HCPCS J-co

This approval represents a new oral suspension formulation of mercaptopurine (NDA205919) by Nova Laboratories, an orphan-designated product billed under Medicare Part D as an oral drug. Mercaptopurine

Ogsiveo (nirogacestat) is an oral tablet approved for desmoid tumors, billing under Medicare Part D as a self-administered drug. As an orphan drug and new molecular entity with no existing J-code, it

This active final LCD from Wellpoint Federal governs coverage of genomic sequence analysis panels used in the treatment of hematolymphoid diseases, effective April 1, 2026. It establishes specific cov

This active final LCD (L38371) from Wellpoint Federal establishes coverage criteria for multimarker serum tests related to ovarian cancer testing, effective April 1, 2026. It governs when Medicare wil

This active final LCD from Wellpoint Federal governs coverage criteria for Proton Beam Therapy under Medicare Part A and Part B, effective April 1, 2026. It establishes the indications, documentation

Retevmo (selpercatinib) is an oral capsule kinase inhibitor approved for RET-driven cancers, billing under Medicare Part D as a self-administered oral oncology drug. As an orphan drug and new molecula

Revtorpyk (gedatolisib), approved July 14, 2026 as a new molecular entity under NDA219908, is a priority-reviewed oncology agent from Celcuity Inc. The drug is presented in a single-dose vial formulat

Retevmo (selpercatinib) was approved in a new oral capsule dosage form under NDA218160, confirming a Part D billing pathway as a self-administered drug. As an oral kinase inhibitor for RET-driven canc

Verzenio (abemaciclib) is an oral tablet CDK4/6 kinase inhibitor approved for breast cancer, billing under Medicare Part D as a self-administered outpatient prescription drug. As an oral oncology agen

Gleevec (imatinib mesylate) is an oral tablet approved under NDA021588 as a new dosage form, billing through Medicare Part D as a self-administered oral medication. As an oral oncology drug, it falls

Padcev (enfortumab vedotin), an injectable antibody-drug conjugate approved for urothelial cancer, is billed under Medicare Part B as a physician-administered injectable drug. As a new molecular entit

This active Final LCD (L33826) governs coverage of oral anticancer drugs under DME MAC jurisdictions, effective January 1, 2026. It establishes billing and coverage criteria for oral cancer medication

Erleada (apalutamide) is an oral tablet approved for prostate cancer, billing through Medicare Part D as a self-administered drug. As an oral oncology agent, it is not eligible for Part B physician-ad

Truxima (rituximab-abbs) is a biosimilar to Rituxan, approved as an injectable CD20-directed cytolytic antibody administered via intravenous infusion, placing it firmly in the Medicare Part B billing

Kisqali Femara Co-Pack (ribociclib + letrozole) is an oral tablet combination approved for hormone receptor-positive, HER2-negative breast cancer, billing under Medicare Part D as a self-administered

Kisqali (ribociclib) is an oral tablet approved under NDA209092, placing it squarely in the Medicare Part D billing pathway as a self-administered outpatient drug. As an oral oncology agent, it is sub