FDA Approval: ALECENSA (ALECTINIB HYDROCHLORIDE) — Type 1 - New Molecular Entity
Policy FDA-NDA208434 • Oncology
HighAlecensa, an oral medication, will fall under Medicare Part D for drug coverage. As it is a new molecular entity and an orphan drug, billing teams should monitor for specific coding and formulary upda
FDA Approval: WELIREG (BELZUTIFAN) — Type 1 - New Molecular Entity
Policy FDA-NDA215383 • Oncology
HighWELIREG (Belzutifan) is an oral medication and will fall under Medicare Part D for coverage. There are no applicable J-codes as it is not an injectable drug, and existing alternatives may affect adopt
FDA Approval: KEYTRUDA QLEX (PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH) — Type 1 - New Molecular Entity
Policy FDA-BLA761467 • Oncology
CriticalKEYTRUDA QLEX, an injectable drug approved under BLA761467, will be billed under Part B. Billing teams should verify the specific J-code upon FDA label publication.
FDA Approval: TZIELD (TEPLIZUMAB-MZWV) — Type 1 - New Molecular Entity
Policy FDA-BLA761183 • Oncology
CriticalWith the approval of TZIELD (teplizumab-mzwv) as an injectable, it is expected to receive a J-code assignment for Medicare billing under Part B. A payment model of ASP + 6% may be applicable, and give
FDA Approval: KEYTRUDA (PEMBROLIZUMAB) — Type 1 - New Molecular Entity
Policy FDA-BLA125514 • Oncology
CriticalKeytruda (pembrolizumab) is an injectable drug that is administered intravenously, likely to receive a J-code for billing under Medicare Part B. Given its classification as an orphan drug and its rele
FDA Approval: YERVOY (IPILIMUMAB) — Type 1 - New Molecular Entity
Policy FDA-BLA125377 • Oncology
CriticalYervoy (ipilimumab) is an injectable drug that may be assigned a J-code for Medicare billing, as it qualifies for Part B coverage due to its injectable nature. It is an orphan drug, which could indica
FDA Approval: OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW) — Type 1 - New Molecular Entity
Policy FDA-BLA761234 • Oncology
HighOPDUALAG, an intravenous injectable drug, will likely receive a specific J-code for Medicare billing due to its status as a new molecular entity. Since it is an oncology drug, it may be eligible for p
FDA Approval: VORANIGO (VORASIDENIB) — Type 1 - New Molecular Entity
Policy FDA-NDA218784 • Oncology
HighAs Voranigo (vorasidenib) is an oral tablet, it will be billed under the Part D pathway. Billing teams should confirm details against the FDA label for any updates related to the drug's billing specif
FDA Approval: HYMPAVZI (MARSTACIMAB-HNCQ) — Type 1 - New Molecular Entity
Policy FDA-BLA761369 • Oncology
HighAs a newly approved subcutaneous injectable, Hympavzi can be billed under Part B. Billing teams should confirm the details regarding its pricing and specific J-code once the FDA label is published.
Proposed LCD DL39927: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms — Noridian
Policy LCD-DL39927 • Oncology
HighThe proposed LCD by Noridian regarding non-next generation sequencing tests may significantly impact billing for BCR-ABL negative myeloproliferative neoplasms by establishing new criteria for coverage
Proposed LCD DL39297: Off-label Use of Rituximab and Rituximab Biosimilars — NGS
Policy LCD-DL39297 • Oncology
HighThe proposed LCD regarding the off-label use of Rituximab and its biosimilars may significantly impact billing practices, as it could lead to changes in coverage policies for these medications. Such m
Proposed LCD DL40142: MolDX: Biomarker Testing for Risk Stratification in DCIS — Palmetto GBA
Policy LCD-DL40142 • Oncology
HighThe proposed LCD on biomarker testing for risk stratification in DCIS could significantly influence billing practices by establishing clear criteria for reimbursement. Providers will need to ensure th
Proposed LCD DL40246: MolDX: Biomarker Testing for Risk Stratification in DCIS — CGS
Policy LCD-DL40246 • Oncology
HighThe proposed LCD for MolDX biomarker testing in DCIS could impact billing by establishing clear criteria for reimbursement, potentially increasing the number of eligible tests approved for coverage. T
Proposed LCD DL40144: MolDX: Biomarker Testing for Risk Stratification in DCIS — Noridian
Policy LCD-DL40144 • Oncology
HighThe proposed Local Coverage Determination (LCD) for MolDX regarding biomarker testing in Ductal Carcinoma In Situ (DCIS) could significantly influence billing by establishing clear guidelines for reim
Proposed LCD DL40251: MolDX: Biomarker Testing for Risk Stratification in DCIS — WPS
Policy LCD-DL40251 • Oncology
HighThe proposed LCD could significantly impact billing for biomarker testing in patients with Ductal Carcinoma In Situ (DCIS). Practices may need to adjust their coding and documentation to align with ne
Proposed LCD DL40210: MolDX: Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer — Palmetto GBA
Policy LCD-DL40210 • Oncology
HighThe proposed Local Coverage Determination (LCD) for Non-Next Generation Sequencing Targeted Molecular Panel Tests could significantly impact billing for oncology practices by defining reimbursement cr
Proposed LCD DL40226: MolDX: Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer — CGS
Policy LCD-DL40226 • Oncology
HighThe proposed LCD on non-next generation sequencing targeted molecular panel tests may significantly impact billing practices for oncology providers. By establishing guidelines for which tests are elig
Proposed LCD DL40222: MolDX: Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer — Noridian
Policy LCD-DL40222 • Oncology
HighThe proposed LCD could potentially impact billing for non-next generation sequencing targeted molecular panel tests used in cancer predictive testing. This may lead to increased scrutiny and changes i
Proposed LCD DL40278: MolDX: Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer — WPS
Policy LCD-DL40278 • Oncology
HighThe proposed Local Coverage Determination (LCD) could significantly affect billing practices for non-next generation sequencing targeted molecular panel tests used in cancer predictive testing. It is
Proposed LCD DL40205: Irreversible Electroporation for Cancer — Palmetto GBA
Policy LCD-DL40205 • Oncology
HighThe proposed Local Coverage Determination (LCD) for Irreversible Electroporation (IRE) could significantly impact reimbursement for cancer treatments. If approved, this will allow healthcare providers
LCD L37794: MolDX: Breast Cancer Index® (BCI) Gene Expression Test — Palmetto GBA
Policy LCD-L37794 • Oncology
HighThe introduction of the Breast Cancer Index® test by Palmetto GBA is affecting the precision of breast cancer treatment decisions. As this test becomes effective in July 2025, providers will need
LCD L38238: MolDX: Predictive Classifiers for Early Stage Non-Small Cell Lung Cancer — Palmetto GBA
Policy LCD-L38238 • Oncology
HighThe introduction of predictive classifiers for early-stage non-small cell lung cancer will have significant implications for billing practices. Providers may need to adjust their coding and documentat
LCD L38292: MolDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease — Palmetto GBA
Policy LCD-L38292 • Oncology
HighThe implementation of the MolDX Prostate Cancer Genomic Classifier Assay is expected to supports compliance with updated rates processes by providing clear coverage guidelines for prostate cancer diagnostics. This could lea
LCD L38566: MolDX: Phenotypic Biomarker Detection in Circulating Tumor Cells — Palmetto GBA
Policy LCD-L38566 • Oncology
HighThe introduction of LCD MolDX for Phenotypic Biomarker Detection in Circulating Tumor Cells may lead to increased compliance updates for oncology providers. Proper coding and documentation will be
LCD L38985: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer — Palmetto GBA
Policy LCD-L38985 • Oncology
HighThe introduction of MolDX for risk-stratifying patients at increased risk for prostate cancer may lead to supports compliance with updated rates opportunities for laboratories performing these biomarker tests. This c
LCD L39297: Off-label Use of Rituximab and Rituximab Biosimilars — NGS
Policy LCD-L39297 • Oncology
HighThe off-label use of Rituximab and its biosimilars may lead to billing challenges under Medicare, as reimbursement is typically based on FDA-approved indications. Providers should ensure comprehensive
LCD L36797: MolDX: NRAS Genetic Testing — WPS
Policy LCD-L36797 • Oncology
HighThe upcoming implementation of the NRAS Genetic Testing LCD by WPS will significantly influence billing procedures for oncology-related services. Providers should anticipate changes in claims submissi
LCD L38678: MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells — WPS
Policy LCD-L38678 • Oncology
HighThe implementation of the MolDX LCD for phenotypic biomarker detection from circulating tumor cells will create significant changes in how tests are reimbursed under Medicare. Providers will need to p
LCD L38920: Off-label Use of Rituximab and Rituximab Biosimilars — CGS
Policy LCD-L38920 • Oncology
HighThe off-label use of Rituximab and its biosimilars may lead to supports compliance with updated rates process, as insurers may require more documentation to justify its medical necessity. Providers sho
LCD L36113: MolDX: MGMT Promoter Methylation Analysis — CGS
Policy LCD-L36113 • Oncology
HighThe implementation of the MGMT Promoter Methylation Analysis LCD may significantly affect billing practices for molecular diagnostics in oncology. Providers will need to ensure compliance with the new
LCD L38067: MolDX: Next-Generation Sequencing for Solid Tumors — CGS
Policy LCD-L38067 • Oncology
HighThe introduction of next-generation sequencing for solid tumors under the MolDX program may enhance the precision of diagnostics and treatment plans, positively impacting patient outcomes. However, pr
LCD L35442: MolDX: NRAS Genetic Testing — CGS
Policy LCD-L35442 • Oncology
HighThe MolDX: NRAS Genetic Testing LCD by CGS, effective from 08/21/2025, may significantly impact billing practices for genetic testing in oncology. Providers will need to familiarize themselves with th
LCD L37001: MolDX: MGMT Promoter Methylation Analysis — WPS
Policy LCD-L37001 • Oncology
HighThe implementation of the MGMT Promoter Methylation Analysis LCD requires billing team review. Additionally, this L
LCD L36951: MolDX: Oncotype DX® Breast Cancer for DCIS (Genomic Health™) — CGS
Policy LCD-L36951 • Oncology
HighThe implementation of the LCD for Oncotype DX® Breast Cancer testing for DCIS could significantly impact billing by providing clear guidelines on coverage and reimbursement for genomic tests. This wil
LCD L36658: Proton Beam Therapy — CGS
Policy LCD-L36658 • Oncology
HighThe implementation of Proton Beam Therapy LCD by CGS could significantly impact billing for facilities utilizing this advanced treatment. It allows for more precise reimbursement guidelines which may
LCD L37628: In Vitro Chemosensitivity & Chemoresistance Assays — Noridian
Policy LCD-L37628 • Oncology
HighThe introduction of LCD for In Vitro Chemosensitivity & Chemoresistance Assays will significantly influence billing practices in oncology, as providers will need to familiarize themselves with new doc
LCD L37630: In Vitro Chemosensitivity & Chemoresistance Assays — Noridian
Policy LCD-L37630 • Oncology
HighThe introduction of the LCD for In Vitro Chemosensitivity and Chemoresistance Assays by Noridian may affect billing practices for oncology services, specifically regarding the appropriate use of relat
LCD L37832: MolDX: Breast Cancer Index® (BCI) Gene Expression Test — CGS
Policy LCD-L37832 • Oncology
HighThe new coverage for the Breast Cancer Index® test may significantly affect billing for oncology practices, allowing for additional reimbursements in relevant patient populations. Accurate coding is e
LCD L38835: MolDX: Minimal Residual Disease Testing for Cancer — WPS
Policy LCD-L38835 • Oncology
HighThe introduction of the LCD for Minimal Residual Disease Testing will create a structured approach to billing for cancer diagnostics, potentially increasing revenue for oncology departments. As this t
LCD L37199: MolDX: Oncotype DX® Breast Cancer for DCIS (Genomic Health™) — WPS
Policy LCD-L37199 • Oncology
HighThe upcoming LCD for Oncotype DX® Breast Cancer testing for DCIS may significantly affect billing procedures for Oncology practices. Providers will need to ensure that appropriate documentation is ava
LCD L36678: Lab: Bladder/Urothelial Tumor Markers — Noridian
Policy LCD-L36678 • Oncology
HighThe introduction of the LCD for Bladder/Urothelial Tumor Markers signifies a future billing change impacting how these lab tests are reimbursed. Providers must prepare for the effective date by ensuri
LCD L38822: MolDX: Minimal Residual Disease Testing for Cancer — CGS
Policy LCD-L38822 • Oncology
HighThe implementation of the MolDX LCD for Minimal Residual Disease Testing will significantly impact billing practices for oncology services. Providers will need to familiarize themselves with the new g
LCD L38284: MolDX: Predictive Classifiers for Early Stage Non-small Cell Lung Cancer — CGS
Policy LCD-L38284 • Oncology
HighThe new LCD for predictive classifiers in early stage non-small cell lung cancer will have a significant impact on billing practices, as it establishes criteria for their coverage under Medicare. Prov
LCD L36680: Lab: Bladder/Urothelial Tumor Markers — Noridian
Policy LCD-L36680 • Oncology
HighThe updated LCD on Bladder/Urothelial Tumor Markers by Noridian may impact billing processes for labs performing these tests. It's crucial for providers to ensure that the services provided align with
LCD L37921: MolDX: Inivata™, InVisionFirst®, Liquid Biopsy for Patients with Lung Cancer — WPS
Policy LCD-L37921 • Oncology
HighThe addition of Inivata™ and InVisionFirst® liquid biopsy tests for lung cancer will enhance the diagnostic capabilities for Medicare patients while introducing potential billing complexity. Effective
LCD L39553: Radiation Therapies — Palmetto GBA
Policy LCD-L39553 • Oncology
HighThe new LCD on Radiation Therapies by Palmetto GBA may affect billing practices significantly. Providers must ensure compliance with the updated guidelines to avoid claim denials and ensure proper rei
LCD L34648: Bisphosphonate Drug Therapy — WPS
Policy LCD-L34648 • Oncology
HighThe implementation of the Bisphosphonate Drug Therapy LCD by WPS effective January 1, 2026, will necessitate adjustments in billing procedures related to bone density therapies. Providers will need to
LCD L33824: Immunosuppressive Drugs — CGS
Policy LCD-L33824 • Oncology
HighThe new local coverage determination (LCD) for immunosuppressive drugs will likely influence billing practices significantly. Providers must ensure that they comply with the updated guidelines to avoi
LCD L33826: Oral Anticancer Drugs — CGS
Policy LCD-L33826 • Oncology
HighThe implementation of the LCD for Oral Anticancer Drugs will likely standardize the billing processes, ensuring providers are adequately reimbursed for these medications. The focus on evidence-based c
LCD L33827: Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics) — CGS
Policy LCD-L33827 • Oncology
HighThe transition from intravenous to oral antiemetic drugs may lead to an supports compliance with updated rates due to the higher administration of oral medications. This change could improve patient complianc