FDA Approval: MIMRYLO (RUSFERTIDE ACETATE) — Type 1 - New Molecular Entity
Policy FDA-NDA220605 • Hematology
HighMIMRYLO (rusfertide acetate) received FDA approval on August 28, 2026, as a new molecular entity with orphan drug designation, but the billing pathway cannot be determined until the FDA label publishe
FDA Approval: EMPAVELI (PEGCETACOPLAN) — Type 1 - New Molecular Entity
Policy FDA-NDA215014 • Hematology
HighEmpaveli (pegcetacoplan) was approved May 14, 2021 as a subcutaneous solution for a rare condition under orphan drug designation, billing under Medicare Part B. As a subcutaneous injectable administer
FDA Approval: ZENBEXUS (IBERDOMIDE) — Type 1 - New Molecular Entity
Policy FDA-NDA221075 • Hematology
HighZenbexus (iberdomide) was approved as an oral capsule, placing it squarely in the Medicare Part D billing pathway as a self-administered drug dispensed through retail or specialty pharmacy. As an orph
FDA Approval: INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA203565 • Hematology
HighInjectafer (ferric carboxymaltose) is an intravenous iron replacement therapy approved for iron deficiency anemia, administered via intravenous infusion and billed under Medicare Part B. This Type 5 s
FDA Approval: ARGATROBAN (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA212035 • Hematology
HighArgatroban is an intravenous anticoagulant with an established Part B billing pathway, administered in inpatient and outpatient hospital settings. This approval (NDA212035) is a Type 5 submission repr
FDA Approval: LYNOZYFIC (LINVOSELTAMAB-GCPT) — Type 1 - New Molecular Entity
Policy FDA-BLA761400 • Hematology
HighLynozyfic (linvoseltamab-gcpt), a newly approved injectable biologic for an orphan indication, will be billed under Medicare Part B given its injection route of administration. As a new molecular enti
FDA Approval: REVLIMID (LENALIDOMIDE) — Type 1 - New Molecular Entity
Policy FDA-NDA021880 • Hematology
RoutineRevlimid (lenalidomide) is an oral capsule approved under priority review as a thalidomide analog, billing through Medicare Part D as a self-administered outpatient drug. As an oral oncology agent, it
FDA Approval: VONJO (PACRITINIB) — Type 1 - New Molecular Entity
Policy FDA-NDA208712 • Hematology
RoutineVonjo (pacritinib) is an oral capsule approved for myelofibrosis, billing through Medicare Part D as a self-administered drug. As an orphan drug kinase inhibitor with no existing J-code, it does not f
FDA Approval: JAKAFI (RUXOLITINIB) — Type 1 - New Molecular Entity
Policy FDA-NDA202192 • Hematology
RoutineJakafi (ruxolitinib) is an oral tablet approved as a New Molecular Entity for a rare condition, placing it squarely in the Medicare Part D billing pathway as a self-administered drug dispensed through
FDA Approval: OJJAARA (MOMELOTINIB) — Type 1 - New Molecular Entity
Policy FDA-NDA216873 • Hematology
RoutineOjjaara (momelotinib), approved September 15, 2023 as an oral tablet, follows a Part D billing pathway as a self-administered drug dispensed through retail or specialty pharmacy. As an orphan drug and
FDA Approval: JAKAFI XR (RUXOLITINIB) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA217180 • Hematology
RoutineJakafi XR (ruxolitinib) is an oral extended-release tablet approved under NDA217180, billing through Medicare Part D as a self-administered drug. As a new formulation of an existing kinase inhibitor w
FDA Approval: INREBIC (FEDRATINIB HYDROCHLORIDE) — Type 1 - New Molecular Entity
Policy FDA-NDA212327 • Hematology
RoutineInrebic (fedratinib hydrochloride) is an oral capsule approved for myelofibrosis, billing under Medicare Part D as a self-administered drug. As an orphan drug with priority review, it is likely a high
FDA Approval: FABHALTA (IPTACOPAN) — Type 1 - New Molecular Entity
Policy FDA-NDA218276 • Hematology
RoutineFabhalta (iptacopan), an oral capsule approved for a rare condition under orphan drug designation, follows a Part D billing pathway as a self-administered oral medication. Billing teams should confirm
FDA Approval: STIMATE (DESMOPRESSIN ACETATE) — Type 3 - New Dosage Form
Policy FDA-NDA020355 • Hematology
RoutineStimate (desmopressin acetate) nasal spray, approved in 1994 as a new dosage form for a rare bleeding disorder indication, is administered intranasally and follows a Part D billing pathway as a self-a
FDA Approval: ARGATROBAN (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA201811 • Hematology
HighArgatroban (Fresenius Kabi USA, NDA201811) is an injectable anticoagulant approved as a new formulation/manufacturer submission, administered via intravenous injection and billed under Medicare Part B
FDA Approval: SARCLISA ESCENA (ISATUXIMAB-IRFC) — Type 3 - New Dosage Form
Policy FDA-BLA761445 • Hematology
HighSarclisa Escena (isatuximab-irfc) was approved as a new subcutaneous dosage form of the existing IV CD38-directed antibody isatuximab, indicated for multiple myeloma under orphan drug designation. As
FDA Approval: BKEMV (ECULIZUMAB-AEEB) — Type 2 - New Active Ingredient
Policy FDA-BLA761333 • Hematology
HighBKEMV (eculizumab-aeeb) is an injectable biosimilar complement inhibitor approved via BLA761333, following the reference product Soliris (eculizumab). As an intravenous injectable, it follows the Part
FDA Approval: ARGATROBAN IN 0.9% SODIUM CHLORIDE (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA206769 • Hematology
HighArgatroban in 0.9% Sodium Chloride (NDA206769) is a new intravenous formulation of the established direct thrombin inhibitor argatroban, approved via a Type 5 submission by Teva Pharmaceuticals. As an
FDA Approval: SARCLISA (ISATUXIMAB) — Type 1 - New Molecular Entity
Policy FDA-BLA761113 • Hematology
HighSarclisa (isatuximab) is an injectable CD38-directed cytolytic antibody approved for multiple myeloma, administered via intravenous injection and billing under Medicare Part B. As a hospital or office
FDA Approval: BESREMI (ROPEGINTERFERON ALFA-2B) — Type 1 - New Molecular Entity
Policy FDA-BLA761166 • Hematology
HighBesremi (ropeginterferon alfa-2b) is a subcutaneously administered injectable approved for polycythemia vera, supporting a Part B billing pathway as a physician-administered drug. As an orphan drug in
FDA Approval: ARGATROBAN (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA209552 • Hematology
HighThe recent FDA approval of Argatroban as an injectable drug suggests it will likely be assigned a J-code for billing under Medicare Part B. Since it is an anticoagulant, providers may receive pass-thr
FDA Approval: ARGATROBAN IN DEXTROSE (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA201743 • Hematology
HighArgatroban in dextrose is an injectable medication that is likely to receive a J-code assignment for Medicare billing. Since it falls under Part B, billing may involve ASP+6% reimbursement if it meets
Proposed LCD DL39923: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms — Noridian
Policy LCD-DL39923 • Hematology
RoutineThe proposed LCD for Non-Next Generation Sequencing Tests could limit coverage for certain diagnostic tests in evaluating BCR-ABL negative myeloproliferative neoplasms. Facilities may see a decrease i
Proposed LCD DL40000: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms — CGS
Policy LCD-DL40000 • Hematology
RoutineThe proposed LCD on non-next generation sequencing tests for diagnosing BCR-ABL negative myeloproliferative neoplasms may lead to changes in reimbursement policies and coverage determinations, impacti
Proposed LCD DL40022: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms — WPS
Policy LCD-DL40022 • Hematology
RoutineThe proposed LCD could significantly impact billing practices for non-next generation sequencing tests used in diagnosing BCR-ABL negative myeloproliferative neoplasms. It may lead to a more stringent
Proposed LCD DL40238: MolDX: Genetic Testing for Hereditary Thrombophilia — Palmetto GBA
Policy LCD-DL40238 • Hematology
RoutineThe proposed LCD on genetic testing for hereditary thrombophilia could influence billing practices related to genetic testing claims. Providers may need to ensure compliance with the new guidelines to
Proposed LCD DL40259: MolDX: Genetic Testing for Hereditary Thrombophilia — CGS
Policy LCD-DL40259 • Hematology
RoutineThe proposed Local Coverage Determination (LCD) for genetic testing related to hereditary thrombophilia could significantly impact claims processing and reimbursement rates for genetic tests in this a
Proposed LCD DL40242: MolDX: Genetic Testing for Hereditary Thrombophilia — Noridian
Policy LCD-DL40242 • Hematology
RoutineThe proposed Local Coverage Determination (LCD) for genetic testing related to hereditary thrombophilia requires billing team review
Proposed LCD DL40274: MolDX: Genetic Testing for Hereditary Thrombophilia — WPS
Policy LCD-DL40274 • Hematology
RoutineThe proposed LCD on genetic testing for hereditary thrombophilia could lead to enhanced coverage for specific tests, impacting the way providers bill for related services. This may increase the number
Proposed LCD DL40334: Erythropoiesis Stimulating Agents — NGS
Policy LCD-DL40334 • Hematology
RoutineThe proposed LCD for Erythropoiesis Stimulating Agents may significantly influence billing practices for providers utilizing these treatments. Depending on the final decision, there could be changes t
LCD L40000: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms — CGS
Policy LCD-L40000 • Hematology
HighThe LCD outlines coverage for non-next generation sequencing tests for diagnosing BCR-ABL negative myeloproliferative neoplasms, which may significantly influence reimbursement policies. Providers wil
LCD L39919: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms — Palmetto GBA
Policy LCD-L39919 • Hematology
HighThe new LCD on Non-Next Generation Sequencing Tests for BCR-ABL Negative Myeloproliferative Neoplasms could lead to supports compliance with updated rates for these tests. This may impact reimbursement rates a
LCD L40022: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms — WPS
Policy LCD-L40022 • Hematology
HighWith the new LCD regarding non-next generation sequencing tests for diagnosing BCR-ABL negative myeloproliferative neoplasms effective from August 17, 2025, providers must ensure adjustments are made
LCD L36400: MolDX: Genetic Testing for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II Prothrombin, and MTHFR) — WPS
Policy LCD-L36400 • Hematology
HighThe implementation of this new LCD on genetic testing for hypercoagulability may create billing complexities for providers. It emphasizes the need for proper documentation and ICD-10 coding to ensure
LCD L36186: MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease — Noridian
Policy LCD-L36186 • Hematology
HighThe implementation of the MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease LCD may impact the billing processes for providers, particularly in the areas of documentation and codi
LCD L36180: MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease — Noridian
Policy LCD-L36180 • Hematology
HighThe implementation of this Local Coverage Determination (LCD) by Noridian may affect the billing process for genetic testing related to BCR-ABL negative myeloproliferative disease. Providers should en
LCD L36117: MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease — CGS
Policy LCD-L36117 • Hematology
HighThe new LCD for genetic testing of BCR-ABL negative myeloproliferative disease will impact billing by establishing specific criteria for coverage, thereby influencing reimbursement rates and patient a
LCD L36044: MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease — Palmetto GBA
Policy LCD-L36044 • Hematology
HighThe recent LCD from Palmetto GBA affects billing for genetic testing related to BCR-ABL Negative Myeloproliferative Disease. Providers must ensure compliance with the updated guidelines to avoid claim
LCD L36815: MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease — WPS
Policy LCD-L36815 • Hematology
HighThe new LCD for genetic testing related to BCR-ABL negative myeloproliferative disease will clarify billing procedures and permissible tests. It is crucial for claims to align with the specified crite
LCD L36155: MolDX: Genetic Testing for Hypercoagulability / Thrombophilia (Factor V Leiden, Factor II Prothrombin, and MTHFR) — Noridian
Policy LCD-L36155 • Hematology
HighThe introduction of the new LCD for genetic testing related to hypercoagulability may have significant billing implications for providers. It will be essential for practices to verify patient eligibil
LCD L36159: MolDX: Genetic Testing for Hypercoagulability / Thrombophilia (Factor V Leiden, Factor II Prothrombin, and MTHFR) — Noridian
Policy LCD-L36159 • Hematology
HighThe new MolDX guidelines for genetic testing related to hypercoagulability and thrombophilia will require careful attention to billing compliance. This may lead to an supports compliance with updated rates inquiries rel
LCD L39923: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms — Noridian
Policy LCD-L39923 • Hematology
HighThe introduction of LCD for non-next generation sequencing tests will impact the billing process for myeloproliferative neoplasms diagnosis, necessitating updates to coding practices. Providers must e
LCD L39927: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms — Noridian
Policy LCD-L39927 • Hematology
HighThe implementation of the LCD for non-next generation sequencing tests for diagnosing BCR-ABL negative myeloproliferative neoplasms requires billing team review
LCD L39396: Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin — Noridian
Policy LCD-L39396 • Hematology
HighThe coverage policy for allogeneic hematopoietic cell transplantation in treating primary refractory or relapsed Hodgkin's and Non-Hodgkin's lymphomas may significantly impact billing practices, as th
LCD L34314: Immune Globulin Intravenous (IVIg) — Noridian
Policy LCD-L34314 • Hematology
HighThe upcoming LCD for Immune Globulin Intravenous (IVIg) may lead to changes in billing practices and reimbursement rates for providers. It is essential for healthcare professionals to prepare for pote
LCD L39434: Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin — CGS
Policy LCD-L39434 • Hematology
HighThe new LCD will impact billing for allogeneic hematopoietic cell transplantation procedures in patients with primary refractory or relapsed lymphoma. Providers should ensure proper coding and documen
LCD L34356: Erythropoiesis Stimulating Agents (ESA) — CGS
Policy LCD-L34356 • Hematology
HighThe introduction of new LCD for Erythropoiesis Stimulating Agents may impact billing procedures due to the specific guidelines outlined by CGS. Providers need to ensure that their documentation suppor
LCD L39398: Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin — Noridian
Policy LCD-L39398 • Hematology
HighThe recent LCD from Noridian for Allogeneic Hematopoietic Cell Transplantation will likely impact billing for providers treating patients with refractory or relapsed Hodgkin's and Non-Hodgkin's Lympho
LCD L38268: Immune Thrombocytopenia (ITP) Therapy — CGS
Policy LCD-L38268 • Hematology
HighThe new LCD for Immune Thrombocytopenia (ITP) therapy set to take effect on March 5, 2026, will impact billing practices for related services. Providers will need to review and adjust their coding and
LCD L35891: Intravenous Immune Globulin — CGS
Policy LCD-L35891 • Hematology
HighThe effective date of the LCD for Intravenous Immune Globulin may affect billing practices as it introduces new criteria for reimbursement. Providers will need to be aware of updated documentation and