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Rituximab (Rituxan, Truxima) and Rituximab and Hyaluronidase Human (Rituxan Hycela)

Section: Injections
Effective Date: August 01, 2019
Revised Date: July 29, 2019

Description

Rituximab (Rituxan ) is a genetically engineered chimeric murine/human monoclonal antibody. It binds specifically to the antigen CD20 (human B-lymphocyte-restricted differentiation antigen, Bp35). This antigen is a hydrophobic transmembrane protein that is located on pre-B and mature B lymphocytes. It is also expressed on more than 90% of B-cell non-Hodgkin’s lymphomas, but it is not expressed on hematopoietic stem cells, pro-B cells, normal plasma cells, or other normal tissues.

Rituximab and hyaluronidase human (Rituxan Hycela™) is a combination of rituximab and hyaluronidase human in a subcutaneous formulation that is given by a healthcare professional after an initial administration of intravenous rituximab (Rituxan). These two products are different formulations and cannot be used interchangeably.

Rituximab-abbs (Truxima®) is a biosimilar of rituximab (Rituxan).

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Rituximab (Rituxan) Intravenous (IV)

Food and Drug Administration (FDA) Approved Indications

Rituximab (Rituxan) may be considered medically necessary for ANY of the following indications:

Rheumatoid Arthritis (RA)

Rituximab for the treatment of adults with RA may be considered medically necessary for the following conditions:

  • RA is moderately to severely active (e.g., greater than or equal to 8 swollen and greater than or equal to eight (8) tender joints); and
  • Rituximab is administered in combination with methotrexate; and
    • Individual has had an inadequate response to one (1) or more tumor necrosis factor inhibitors; or
    • Individual has had an inadequate response to methotrexate or other conventional synthetic disease-modifying anti-rheumatic drug and is not suitable for treatment with tumor necrosis factor inhibitors (e.g., due to a recent [e.g., within five (5) years] history of lymphoma or other malignancy; latent tuberculosis and contraindications to chemoprophylaxis; or previous demyelinating disease).

Antineutrophil Cytoplasmic Antibody's Associated Vasculitides (Granulomatosis with Polyangiitis [Wegener Granulomatosis] and Microscopic Polyangiitis)

Rituximab (Rituxan), in combination with glucocorticoids, may be considered medically necessary for the treatment of individuals with antineutrophil cytoplasmic antibody-associated vasculitides (i.e., granulomatosis with polyangiitis (GPA) [Wegener granulomatosis] and microscopic polyangiitis).

Non-Hodgkin's Lymphoma (NHL)

Rituximab (Rituxan) may be considered medically necessary for the treatment of NHL which is:

  • Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent; or
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in individuals achieving a complete or partial response to RITUXAN in combination with chemotherapy, as single-agent maintenance therapy; or
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; or
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.

Chronic Lymphocytic Leukemia (CLL)

Rituximab (Rituxan) may be considered medically necessary for the treatment of previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).

Pemphigus Vulgaris (PV)

Rituximab (Rituxan) may be considered medically necessary for the treatment of moderate to severe PV in adult individuals.

The use of rituximab (Rituxan) for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes

J9312

Other clinically supported indications

Rituximab (Rituxan) may be considered medically necessary for the following off-label indications:

Autoimmune Hemolytic Anemia (AIHA)

Rituximab (Rituxan) may be considered medically necessary for the treatment of EITHER of the following AIHA:

  • Warm AIHA in glucocorticoid-refractory or glucocorticoid-dependent individuals; or
  • Cold agglutination syndrome.

Thrombotic Thrombocytopenic Purpura

Rituximab (Rituxan) may be considered medically necessary for the treatment of thrombotic thrombocytopenic purpura in individuals with refractory disease or relapse (i.e., lack of response to plasma exchange therapy and glucocorticoids).

Churg-Strauss Syndrome (Eosinophilic Granulomatosis with Polyangiitis)

Rituximab (Rituxan) may be considered medically necessary as treatment for Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis):

  • First-line treatment in combination with glucocorticoids for individuals with severe (organ-threatening) disease; or
  • Add-on therapy for treatment-refractory disease.

Hemophilia

Rituximab (Rituxan) may be considered medically necessary for the treatment of hemophilia with acquired inhibitors who are refractory to conventional first line treatments (i.e. immunosuppression with prednisone and cyclophosphamide).

Hepatitis C Virus's Associated Cryoglobulinemic Vasculitis

Rituximab (Rituxan) may be considered medically necessary as add-on therapy for individuals with hepatitis C virus's associated cryoglobulinemic vasculitis who have:

  • Active disease resistant to antiviral drugs; or
  • Severe or life-threatening cryoglobulinemic vasculitis.

Multicentric Castleman Disease Associated with Human Herpesvirus 8 (HHV-8) in HIV-Infected Individuals

Rituximab (Rituxan) may be considered medically necessary as treatment for multicentric Castleman disease (first- or second-line therapy).

Neuromyelitis Optica

Rituximab (Rituxan) may be considered medically necessary as treatment for neuromyelitis optica for relapse prevention.

Pemphigoid Diseases

Rituximab (Rituxan) may be considered medically necessary as treatment for ANY of the following pemphigoid diseases in treatment-refractory individuals:

  • Bullous pemphigoid; or
  • Mucous membrane pemphigoid, including ocular cicatricial pemphigoid; or
  • Epidermolysis bullosa acquisita.

Pemphigus Diseases

Rituximab (Rituxan) may be considered medically necessary as treatment for pemphigus diseases (i.e., pemphigus vulgaris, pemphigus foliaceus, and paraneoplastic pemphigus).

Primary Sj gren Syndrome

Rituximab (Rituxan) may be considered medically necessary as treatment for primary Sj gren syndrome that is refractory to glucocorticoids and at least two other immunosuppressive agents (e.g. cyclosporine, methotrexate, azathioprine, corticosteroids, etc.).

Systemic Lupus Erythematosus

Rituximab (Rituxan) may be considered medically necessary as add-on therapy for systemic lupus erythematosus refractory to standard first-line treatment.

Lupus Nephritis

Rituximab (Rituxan) may be considered medically necessary as add-on therapy for lupus nephritis refractory to standard first-line treatment regimen.

Systemic Sclerosis (Scleroderma)

Rituximab (Rituxan) may be considered medically necessary as treatment for systemic sclerosis (scleroderma) in individuals refractory to first-line treatment.

Glucocorticoid-Refractory Chronic Graft-Versus-Host Disease

Rituximab (Rituxan) may be considered medically necessary as treatment for glucocorticoid-refractory chronic graft-versus-host disease.

Desensitization of Human Leukocyte Antigen€’Sensitized Renal Transplant Candidates

Rituximab (Rituxan) may be considered medically necessary for desensitization of human leukocyte antigen€’sensitized renal transplant candidates before transplantation.

Idiopathic Membranous Nephropathy

Rituximab (Rituxan) may be considered medically necessary as treatment for idiopathic membranous nephropathy.

Epstein-Barr virus disease; Prophylaxis – Hemopoietic stem cell transplant

Rituximab (Rituxan) may be considered medically necessary for the prevention of Epstein Barr virus infection in hematopoietic stem cell transplant individuals.

Evans syndrome (Pediatric only)

Rituximab (Rituxan) may be considered medically necessary as treatment for Evans syndrome refractory to immunosuppressive therapy.

Idiopathic Thrombocytopenic purpura (Adult only)

Rituximab (Rituxan) may be considered medically necessary as treatment for idiopathic thrombocytopenic purpura.

Immune thrombocytopenia, previously treated (Pediatric only)

Rituximab (Rituxan) may be considered medically necessary as treatment for previously treated immune thrombocytopenia.

Microscopic polyarteritis nodosa (Adult only)

Rituximab (Rituxan) may be considered medically necessary as treatment for microscopic polyarteritis nodosa in combination with glucocorticoids.

Minimal change disease (Pediatric only)

Rituximab (Rituxan) may be considered medically necessary as treatment for refractory, steroid-dependent or steroid-resistant minimal change disease when:

  • Remission induction and maintenance of remission of refractory steroid-resistant or steroid-dependent nephrotic syndrome.

Relapsing-Remitting Multiple Sclerosis

Rituximab (Rituxan) may be considered medically necessary as treatment for relapsing-remitting multiple sclerosis when:

  • The member has experienced therapeutic failure, intolerance, or contraindication to two alternative drug therapies indicated for the treatment of multiple sclerosis (e.g. Avonex, Aubagio, Gilenya, etc.).

Myasthenia Gravis

Rituximab (Rituxan) may be considered medically necessary as treatment for relapsed or refractory myasthenia gravis in individuals who have failed to respond to, or are intolerant to, conventional therapy, including azathioprine.

Idiopathic Inflammatory Myopathy

Rituximab (Rituxan) may be considered medically necessary as treatment for refractory idiopathic inflammatory myopathy in individuals who have failed to respond to, or are intolerant to, another immunosuppressant (e.g. methotrexate).

The use of rituximab for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes

J9312

National Comprehensive Cancer Network (NCCN) Approved Indications

Rituximab (Rituxan) may be considered medically necessary for ANY of the following indications:

Central nervous system cancers Leptomeningeal metastases

  • Intra-cerebrospinal fluid (CSF) treatment for leptomeningeal metastases from lymphomas for:
    • Primary treatment in individuals with normal CSF flow or no clinical evidence of abnormal flow; or
    • Maintenance treatment in individuals with negative CSF cytology or in clinically stable individuals with persistently positive CSF cytology; or
    • Treatment in individuals with positive CSF cytology.

Primary CNS Lymphoma:

  • Induction therapy:
    • In combination with high-dose methotrexate; or
    • In combination with high-dose methotrexate and temozolomide; or
    • As a component of R-MPV (rituximab, methotrexate, procarbazine, and vincristine) regimen; or
    • In combination with high-dose methotrexate and temozolomide followed by post-RT temozolomide; or
  • Consider as intra-CSF therapy if CSF positive or spinal MRI positive; or
  • Consider for consolidation therapy in individuals with complete response or complete response unconfirmed (CRu) to induction therapy:
    • In combination with high-dose methotrexate; or
    • In combination with high-dose methotrexate and temozolomide; or
    • As a component of R-MPV (rituximab, methotrexate, procarbazine, and vincristine) regimen; or
    • In combination with high-dose methotrexate and temozolomide followed by post-RT temozolomide; or
  • Treatment as a single agent or in combination with temozolomide, lenalidomide, or high-dose methotrexate for relapsed or refractory disease:
    • May be considered in individuals who received prior whole brain radiation therapy (RT); or
    • In individuals who received a prior high-dose methotrexate-based regimen without prior RT after previous response with long duration (greater than or equal to 12 months) to prior regimen; or
    • In combination with whole brain RT or involved field RT in individuals who received a prior high-dose methotrexate-based regimen without prior RT after no response or short response duration (less than 12 months) to prior regimen; or
    • In individuals who received prior high-dose chemotherapy with stem cell rescue after previous response with long duration (greater than or equal to 12 months).

Hodgkin Lymphoma

  • For Nodular Lymphocyte-Predominant Hodgkin Lymphoma in individuals age greater than or equal to 18 years:
    • Primary treatment in combination with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) + rituximab, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) + rituximab, or CVP (cyclophosphamide, vinblastine, prednisolone) + rituximab:
      • With involved site radiation therapy (ISRT) for stage IA or IIA disease (bulky): or
      • With ISRT for stage IB or IIB disease; or
      • With or without ISRT for stage III-IV disease; or
    • Primary treatment as a single agent for stage IIIA or IVA disease; or
    • Second-line or subsequent systemic therapy (if not previously used) for progressive, relapsed, or refractory disease as a single agent, with or without ISRT; or
    • May be considered as maintenance therapy for individuals treated with second-line systemic therapy with rituximab alone for progressive, relapsed, or refractory disease; or
    • Second-line or subsequent systemic therapy (if not previously used) for progressive, relapsed, or refractory disease in combination with:
      • DHAP (dexamethasone, cisplatin, and high-dose cytarabine), with or without ISRT; or
      • ESHAP (etoposide, methylprednisolone, high-dose cytarabine, and cisplatin), with or without ISRT; or
      • ICE (ifosfamide, carboplatin, and etoposide), with or without ISRT; or
      • IGEV (ifosfamide, gemcitabine, and vinorelbine), with or without ISRT.

Non-Hodgkin Lymphomas

AIDS-Related, B-Cell Lymphoma

  • Preferred** treatment in combination with growth factor support for AIDS-related Burkitt lymphoma as a component of:
    • R-EPOCH (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen; or
    • Modified CODOX-M (cyclophosphamide, doxorubicin, and vincristine, with intrathecal methotrexate and cytarabine followed by high-dose systemic methotrexate) regimen alternating with IVAC (ifosfamide, cytarabine, etoposide, and intrathecal methotrexate) regimen with or without rituximab; or
  • In combination with growth factor support for AIDS-related Burkitt lymphoma as a component of R-HyperCVAD (rituximab, cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine) regimen; or
  • Second-line therapy for relapse of AIDS-related Burkitt lymphoma as a component of:
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab (if not previously given as first-line therapy); or
    • RICE (rituximab, ifosfamide, carboplatin, and etoposide) regimen in combination with intrathecal methotrexate (if not previously given); or
    • RIVAC (rituximab, ifosfamide, cytarabine, etoposide) regimen in combination with intrathecal methotrexate (if not previously given); or
    • RGDP (rituximab, gemcitabine, dexamethasone, cisplatin) regimen; or
    • High-dose cytarabine and rituximab regimen; or
  • Preferred** treatment In combination with growth factor support for CD20+ AIDS-related diffuse large B-cell lymphoma and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified (NOS) as a component of R-EPOCH (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen; or
  • In combination with growth factor support for CD20+ AIDS-related diffuse large B-cell lymphoma and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified (NOS) as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen with rituximab; or
  • Second-line therapy or subsequent therapy for relapse of AIDS-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified (NOS):
    • For individuals with intention to proceed to transplant as a component of DHAP (dexamethasone, cisplatin, and cytarabine), DHAX (dexamethasone, cytarabine, and oxaliplatin), ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin), GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin), GemOX (gemcitabine and oxaliplatin), ICE (ifosfamide, carboplatin, and etoposide), or MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen with rituximab; or
    • Noncandidates for transplant as a single agent, in combination with lenalidomide (for non-germinal center diffuse large B-cell lymphoma) or bendamustine, with gemcitabine and vinorelbine, or as a component of CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine), dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin), CEOP (cyclophosphamide, etoposide, vincristine, and prednisone), GDP, or GemOX regimen with rituximab.

Burkitt Lymphoma

  • Induction therapy for low-risk disease as a component of:
    • CODOX-M (cyclophosphamide, doxorubicin, and vincristine, with intrathecal methotrexate and cytarabine followed by high-dose systemic methotrexate) regimen (original or modified) regimen with rituximab; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab and intrathecal methotrexate; or
    • HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen with rituximab (regimen includes intrathecal therapy); or
  • Induction therapy for high-risk disease as a component of:
    • CODOX-M (cyclophosphamide, doxorubicin, and vincristine, with intrathecal methotrexate and cytarabine followed by high-dose systemic methotrexate) regimen (original or modified) alternating with IVAC (ifosfamide, cytarabine, etoposide, and intrathecal methotrexate) regimen with rituximab; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab and intrathecal methotrexate for individuals not able to tolerate aggressive therapy; or
    • Hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen with rituximab (regimen includes intrathecal therapy); or
  • Used as a component of dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab and intrathecal methotrexate, RICE (rituximab, ifosfamide, carboplatin, and etoposide) regimen with intrathecal methotrexate if not previously given, RIVAC (rituximab, ifosfamide, cytarabine, and etoposide) regimen with intrathecal methotrexate if not previously given, RGDP (rituximab, gemcitabine, dexamethasone, and cisplatin) regimen, or HDAC (high-dose cytarabine) with rituximab regimen:
    • As second-line therapy for relapse of Burkitt lymphoma greater than six (6) months following complete response to induction therapy; or
    • For individuals with partial response to second-line therapy as additional second-line therapy (if not previously given) for relapse or refractory disease.

Castleman’s Disease (CD)

  • Used for unicentric CD with or without prednisone and/or cyclophosphamide:
    • For surgically unresectable disease; or
    • For symptomatic disease following incomplete resection; or
    • As second-line therapy for relapsed or refractory disease; or
  • Therapy for active multicentric CD with no organ failure with or without prednisone for individuals who are human immunodeficiency virus-negative and human herpesvirus-8-negative:
    • As primary treatment; or
    • For relapsed disease; or
    • If no response to primary treatment; or
  • Therapy for active multicentric CD with no organ failure with or without liposomal doxorubicin and/or prednisone for individuals who are human herpesvirus-8-positive:
    • As preferred** primary treatment; or
    • For relapsed disease; or
    • If no response to primary treatment; or
  • Used with or without prednisone for active multicentric CD with no organ failure for progression greater than or equal to six (6) months following completion of rituximab; or
  • Primary treatment for multicentric CD for individuals with fulminant human herpesvirus-8 with or without organ failure:
    • In combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • In combination with CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) regimen; or
    • In combination with CVP (cyclophosphamide, vincristine, and prednisone) regimen; or
    • In combination with Liposomal doxorubicin; or
    • As a single agent if individual is not a candidate for combination therapy; or
  • Treatment for refractory or progressive multicentric CD in combination with liposomal doxorubicin or with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone), or CVP (cyclophosphamide, vincristine, and prednisone) regimen:
    • As initial treatment; or
    • If no response to initial treatment for refractory or progressive disease; or
  • Subsequent therapy for multicentric CD that has progressed following treatment of relapsed/refractory or progressive disease in combination with:
    • Bortezomib; or
    • Lenalidomide; or
    • Thalidomide.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

  • First-line therapy for disease without del(17p)/TP53 mutation in frail individuals with significant comorbidity who are not able to tolerate purine analogs:
    • In combination with chlorambucil (preferred regimen**); or
    • In combination with high-dose methylprednisolone; or
  • First-line therapy for disease without del(17p)/TP53 mutation in individuals age greater than or equal 65 years and younger individuals with significant comorbidities:
    • In combination with chlorambucil, or bendamustine (preferred regimens**); or
  • First-line therapy for disease without del(17p)/TP53 mutation in individuals age less than 65 years without significant comorbidities:
    • As a component of FCR (fludarabine, cyclophosphamide) with rituximab (preferred regimen**); or
    • In combination with bendamustine (preferred regimen**); or
    • In combination with high-dose methylprednisolone; or
  • First-line therapy for disease with del(17p)/TP53 mutation in combination with alemtuzumab or high-dose methylprednisolone; or
  • First line therapy in combination with fludarabine for disease without del(17p)/TP53 and del(11q) mutations in individuals age less than 65 years without significant comorbidities; or
  • Therapy for relapsed or refractory disease without del(17p)/TP53 mutation in frail individuals with significant comorbidity or age greater than or equal to 65 years and younger individuals with significant comorbidities:
    • In combination with idelalisib or venetoclax (preferred regimens**); or
    • As a single agent in a dose-dense regimen; or
    • In combination with alemtuzumab, bendamustine with or without ibrutinib, chlorambucil. lenalidomide, or high-dose methylprednisolone; or
    • As a component of reduced-dose FCR (fludarabine, cyclophosphamide, and rituximab) or reduced-dose PCR (pentostatin, cyclophosphamide, and rituximab) regimen; or
  • Therapy for relapsed or refractory disease without del(17p)/TP53 mutation in individuals less than 65 years without significant comorbidities:
    • In combination with idelalisib or venetoclax (preferred regimens**); or
    • In combination with alemtuzumab, bendamustine with or without ibrutinib or idelalisib, high-dose methylprednisolone, or lenalidomide; or
    • As a component of FCR (fludarabine, cyclophosphamide, and rituximab) or PCR (pentostatin, cyclophosphamide, and rituximab) regimen; or
  • Therapy for relapsed or refractory disease with del(17p)/TP53 in combination with:
    • IIelalisib or venetoclax (preferred regimens**); or
    • Alemtuzumab, lenalidomide, or high-dose methylprednisolone; or
  • Initial therapy for histologic (Richter’s) transformation to diffuse large B-cell lymphoma (clonally related or unknown clonal status) as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) with rituximab regimen; or
    • HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) with rituximab regimen alternating with high-dose methotrexate and cytarabine regimen; or
    • OFAR (oxaliplatin, fludarabine, cytarabine, and rituximab) regimen.

Diffuse Large B-Cell Lymphoma

  • First-line therapy for stage I-II disease as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
  • First-line therapy for stage I-II disease for individuals with poor left ventricular function as a component of:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen; or
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone) regimen; or
  • First-line therapy for stage I-II disease for very frail individuals and individuals greater than 80 years of age with comorbidities as a component of:
    • RCEPP regimen; or
    • RCDOP regimen; or
    • R-mini-CHOP; or
    • RGCVP regimen; or
  • First-line therapy for stage III-IV disease as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
  • First-line therapy for stage III-IV disease in individuals with poor left ventricular function as a component of:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH regimen with rituximab; or
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen; or
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone) regimen; or
  • First-line therapy for stage III-IV disease for very frail individuals and individuals greater than 80 years of age with comorbidities as a component of:
    • RCEPP regimen; or
    • RCDOP regimen; or
    • R-mini-CHOP; or
    • RGCVP regimen; or
  • Second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease in:
    • Individuals with intention to proceed to transplant as a component of DHAP (dexamethasone, cisplatin, and cytarabine), DHAX (dexamethasone, cytarabine, and oxaliplatin), ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin), GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin), GemOX (gemcitabine and oxaliplatin), ICE (ifosfamide, carboplatin, and etoposide), or MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen with rituximab; or
    • Noncandidates for transplant as a single agent, in combination with lenalidomide (non-germinal center lymphoma) or bendamustine, or as a component of CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine), dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin), CEOP (cyclophosphamide, etoposide, vincristine, and prednisone), GDP, GemOX; or
  • First-line therapy for primary mediastinal large B-cell lymphoma as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
    • Dose-dense RCHOP regimen followed by ICE (ifosfamide, carboplatin, and etoposide) regimen; or
  • First-line therapy for grey zone lymphoma as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
  • First-line therapy for grey zone lymphoma for individuals with poor left ventricular function as a component of:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH regimen with rituximab; or
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen; or
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone) regimen; or
  • First-line therapy for grey zone lymphoma for very frail individuals and individuals greater than 80 years of age with comorbidities as a component of:
    • RCEPP regimen; or
    • RCDOP regimen; or
    • R-mini-CHOP; or
    • RGCVP regimen; or
  • First-line therapy for primary cutaneous diffuse large B-cell lymphoma, leg type as a treatment for solitary regional, T1-2 disease (with involved site radiation therapy) or generalized cutaneous, T3 disease:
    • As a component of RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
  • First-line therapy for primary cutaneous diffuse large B-cell lymphoma, leg type as a treatment for solitary regional, T1-2 disease (with involved site radiation therapy) or generalized cutaneous, T3 disease in individuals with poor left ventricular function as a component of:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen; or
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone) regimen; or
  • First-line therapy for primary cutaneous diffuse large B-cell lymphoma, leg type as a treatment for solitary regional, T1-2 disease (with involved site radiation therapy) or generalized cutaneous, T3 disease for very frail individuals and individuals greater than 80 years of age with comorbidities as a component of:
    • RCEPP regimen; or
    • RCDOP regimen; or
    • R-mini-CHOP; or
    • RGCVP regimen.
  • First-line therapy for extracutaneous primary cutaneous diffuse large B-cell lymphoma, leg type as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
  • First-line therapy for extracutaneous primary cutaneous diffuse large B-cell lymphoma, leg type for individuals with poor left ventricular function as a component of:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH regimen with rituximab; or
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen; or
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone) regimen; or
  • First-line therapy for extracutaneous primary cutaneous diffuse large B-cell lymphoma, leg type for very frail individuals and individuals >80 years of age with comorbidities as a component of:
    • RCEPP regimen; or
    • RCDOP regimen; or
    • R-mini-CHOP; or
    • RGCVP regimen; or
  • Second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory primary cutaneous diffuse large B-cell lymphoma, leg type:
    • As a component of DHAP (dexamethasone, cisplatin, and cytarabine), DHAX (dexamethasone, cytarabine, and oxaliplatin), ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin), GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin), GemOX (gemcitabine and oxaliplatin), ICE (ifosfamide, carboplatin, and etoposide), or MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen with rituximab in individuals with intention to proceed to transplant; or
    • As a single agent, in combination with lenalidomide (non-germinal center lymphoma) or bendamustine, or as a component of CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine), dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin), CEOP (cyclophosphamide, etoposide, vincristine, and prednisone), GDP, GemOX, or gemcitabine in noncandidates for transplant.

High-Grade B-Cell Lymphomas

  • Used as induction therapy for high-grade B-cell lymphomas with translocations of MYC and BCL2 and/or BCL6 (double/triple hit lymphoma) or high-grade B-cell lymphomas, not otherwise specified as a component of:
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
    • Hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen with rituximab; or
    • R-CODOX-M (rituximab, cyclophosphamide, vincristine, and doxorubicin with methotrexate) regimen alternating with R-IVAC (rituximab, ifosfamide, etoposide, and cytarabine) regimen; or
  • Used as induction therapy for high-grade B-cell lymphomas, not otherwise specified* as a component of RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
  • Second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease in:
    • Individuals with intention to proceed to transplant as a component of DHAP (dexamethasone, cisplatin, and cytarabine), DHAX (dexamethasone, cytarabine, and oxliplatin), ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin), GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin), GemOX (gemcitabine and oxaliplatin), ICE (ifosfamide, carboplatin, and etoposide), or MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen with rituximab; or
    • Noncandidates for transplant as a single agent, in combination with lenalidomide (non-germinal center lymphoma) or bendamustine, or as a component of CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine), dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin), CEOP (cyclophosphamide, etoposide, vincristine, and prednisone), GDP, GemOX, or gemcitabine and vinorelbine regimen with rituximab

*RCHOP has been associated with inferior outcomes for individuals with highgrade B-cell lymphomas with translocations of MYC and BCL2 and/or BCL6 (double/triple hit lymphoma).

Follicular Lymphoma (grade 1-2)

  • Preferred** first-line therapy for stage I (greater than or equal to seven (7) cm), contiguous stage II (greater than or equal to seven (7) cm), non-contiguous stage II disease, or for individuals with the indications for treatment with stage III or IV disease as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen; or
    • Bendamustine with rituximab; or
  • Used as a single agent in elderly or infirm individuals when tolerability of combination chemotherapy is a concern as:
    • Preferred first-line therapy for stage I (‰7 cm), contiguous stage II (‰7 cm), non-contiguous stage II disease, or for individuals with indications for treatment with stage III or IV disease; or
    • Preferred second-line or subsequent therapy (if not previously given as first-line) for refractory or progressive disease in individuals with indications for treatment; or
  • Used in elderly or infirm individuals with indications for treatment in combination with chlorambucil or in combination with cyclophosphamide as:
    • First-line therapy for stage I (greater than or equal to seven (7) cm), contiguous stage II (greater than or equal to seven (7) cm), non-contiguous stage II disease, or for individuals with indications for treatment with stage III or IV disease; or
    • Second-line or subsequent therapy (if not previously given as firstline) for refractory or progressive disease in individuals with indications for treatment; or
  • First-line therapy for stage I (greater than or equal to seven (7) cm), contiguous stage II (greater than or equal to seven (7) cm) non-contiguous stage II disease, or for individuals with indications for treatment with stage III or IV disease in combination with lenalidomide (preferred regimen**) or as a single agent (consider in individuals that were initially observed and have progressed with a low tumor burden); or
  • First-line therapy for stage I, II pediatric-type follicular lymphoma in adults with extensive local disease who are not candidates for excision or involved site radiation therapy as a component of RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) regimen; or
  • First-line consolidation therapy in individuals with indications for treatment if initially treated with single-agent rituximab.
  • Second-line or subsequent therapy for refractory or progressive disease in individuals with indications for treatment as a single agent or in combination with:
    • Bendamustine (preferred**, if not previously given as first-line); or
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen (preferred**, if not previously given as first-line); or
    • RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen (preferred**, if not previously given as first-line); or
    • Lenalidomide (preferred**, if not previously given as first line); or
    • DHAP (dexamethasone, cisplatin, and cytarabine) regimen; or
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen; or
    • ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) regimen; or
    • GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin) regimen; or
    • GemOX (gemcitabine and oxaliplatin) regimen; or
    • ICE (ifosfamide, carboplatin, and etoposide) regimen; or
    • MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen; or
    • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen; or
    • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen; or
    • Lenalidomide; or
    • Gemcitabine and vinorelbine; or
  • Treatment of histologic transformation to diffuse large B-cell lymphoma (DLBCL) without translocations of MYC and BCL2 and/or BCL6 in individuals who have received minimal or no prior chemotherapy as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-dense RCHOP-14; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) and rituximab regimen; or
  • Treatment of histologic transformation to DLBCL without translocations of MYC and BCL2 and/or BCL6 in individuals who have received minimal or no prior chemotherapy and have poor left ventricular function as a component of:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen; or
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine and prednisolone) regimen; or
  • Treatment of histologic transformation to DLBCL without translocations of
  • MYC and BCL2 and/or BCL6 in individuals who have received minimal or no prior chemotherapy and are very frail and for individuals greater than 80 years of age with comorbidities as a component of:
    • RCEPP regimen; or
    • RCDOP regimen; or
    • R-mini-CHOP regimen; or
    • RGCVP regimen; or
  • Treatment of histologic transformation to DLBCL with translocations of MYC and BCL2 and/or BCL6 in individuals who have received minimal or no prior chemotherapy as a component of;
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
    • HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen with rituximab; or
    • R-CODOX-M (rituximab, cyclophosphamide, vincristine, and doxorubicin with methotrexate) regimen alternating with R-IVAC (rituximab, ifosfamide, etoposide, and cytarabine) regimen; or
  • Treatment of histologic transformation to DLBCL in individuals who have received multiple lines of chemoimmunotherapy for indolent or transformed disease as a single agent or in combination with:
    • Bendamustine; or
    • DHAP (dexamethasone, cisplatin, and cytarabine) regimen; or
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen; or
    • ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) regimen; or
    • GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin) regimen; or
    • GemOX (gemcitabine and oxaliplatin) regimen; or
    • ICE (ifosfamide, carboplatin, and etoposide) regimen; or
    • MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen; or
    • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen; or
    • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen; or
    • Lenalidomide; or
    • Gemcitabine and vinorelbine; or
  • First-line consolidation therapy in individuals with indications for treatment if initially treated with single-agent rituximab; or
  • Maintenance therapy:
    • As first-line or second-line consolidation or extended dosing in individuals initially presenting with high tumor burden (stage III, IV) who achieve a complete or partial response following treatment with RCHOP (rituximab, cyclophosphamide,doxorubicin, and prednisone) regimen or RCVP (rituximab, cyclophosphamide, vincristine and prednisone) regimen; or
    • Second-line consolidation or extended dosing; or
    • Can be considered for individuals with histologic transformation to diffuse large B-cell lymphoma that is coexisting with extensive follicular lymphoma who achieve a complete response to chemoimmunotherapy.

Gastric MALT Lymphoma

  • Initial therapy (if involved site radiation therapy is contraindicated) as a single agent for individuals with H. pylori-negative stage I1, or I2, or stage II1 disease or for H. pylori-positive individuals with t (11;18) who, following antibiotic treatment, are lymphoma positive after endoscopy for restaging; or
  • Preferred for individuals with indication for treatment as a component of RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen or in combination with Bendamustine:
    • As first-line therapy for stage IIE, or II2, or stage IV disease (distant nodal, advanced stage); or
    • As additional therapy for stage I1, or I2, or stage II1 H. pylori positive disease if repeat endoscopy shows no response or recurrence after antibiotic therapy and involved site radiation therapy (ISRT); or
    • As additional therapy after ISRT or rituximab alone for stage I1, or I2, or stage II1 disease that is lymphoma positive after restaging with endoscopy; or
  • Used as a single agent in individuals with indications for treatment as:
    • First-line therapy for stage IIE, or II2, or stage IV (distant nodal or advanced stage); or
    • Additional therapy for stage I1, or I2, or stage II1 H. pylori positive disease if repeat endoscopy shows no response or recurrence after antibiotic therapy and ISRT; or
    • Additional therapy after involved site radiation therapy ISRT alone for stage I1, or I2, or stage II1 disease that is lymphoma positive after restaging with endoscopy; or
  • Used in combination with lenalidomide for individuals with indications for treatment as:
    • First-line therapy for stage IIE, or II2, or stage IV disease (distant nodal or advanced stage); or
    • Additional therapy for stage I1, or I2, or stage II1 H. pylori positive disease if repeat endoscopy shows no response or recurrence after antibiotic therapy and ISRT; or
    • Additional therapy after ISRT or rituximab alone) for stage I1, or I2, or stage II1 disease that is lymphoma positive after restaging with endoscopy; or
  • Used as a single agent (preferred**) or in combination with chlorambucil or cyclophosphamide in elderly or infirm individuals with indications for treatment when tolerability of combination chemotherapy is a concern as;
    • First-line therapy for stage IIE, or II2, or stage IV (distant nodal or advanced stage) disease; or
    • Additional therapy for stage I1, or I2, or stage II1 H. pylori positive disease if repeat endoscopy shows no response or recurrence after antibiotic therapy and ISRT; or
    • Additional therapy after ISRT or rituximab alone for stage I1, or I2, or stage II1 disease that is lymphoma positive after restaging with endoscopy; or
  • Consolidation as optional first-line extended therapy in individuals initially treated with single agent rituximab; or
  • Second-line therapy or subsequent therapy for recurrent or progressive disease in individuals with indications for treatment as a single agent or:
    • In combination with Bendamustine; or
    • As a component of RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • As a component of RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen; or
    • In combination with Lenalidomide.

Nongastric MALT Lymphoma

  • First-line therapy for stage I-II disease in selected cases; or
  • Preferred** first-line therapy for stage IV disease or recurrent stage I-II disease in individuals with indications for treatment as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen; or
    • Bendamustine with rituximab; or
  • First-line therapy as a single agent or in combination with lenalidomide for stage IV disease or recurrent stage I-II disease in individuals with indications for treatment; or
  • Used as a single agent or in combination with chlorambucil or cyclophosphamide for stage IV disease or recurrent stage I-II disease in elderly or infirm individuals with indications for treatment when tolerability of combination chemotherapy is a concern as:
    • First-line therapy; or
    • Second-line or subsequent therapy; or
  • Second-line or subsequent therapy for refractory or progressive disease in individuals with indications for treatment as a single agent or in:
    • Bendamustine with rituximab; or
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen; or
    • Lenalidomide with rituximab; or
  • Consolidation as optional first-line extended therapy in individuals initially treated with single agent rituximab.

Nodal Marginal Zone Lymphoma

  • Used as a single agent (preferred**) or in combination with chlorambucil or cyclophosphamide for stage I (greater than or equal to seven (7) cm), contiguous stage II (greater than or equal to seven (7) cm), non-contiguous stage II, or stage III, IV disease in elderly or infirm individuals with indications for treatment when tolerability of combination chemotherapy is a concern as:
    • First-line therapy; or
    • Second-line or subsequent therapy; or
  • Preferred** first-line therapy for stage I (greater than or equal to seven (7) cm), contiguous stage II (greater than or equal to seven (7) cm), non-contiguous stage II, or stage III, or IV disease in individuals with indications for treatment in combination with bendamustine or as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen; or
  • First-line therapy as a single agent or in combination with lenalidomide for stage I (greater than or equal to seven (7) cm), contiguous stage II (greater than or equal to seven (7) cm), non-contiguous stage II, or stage III, IV disease in individuals with indications for treatment; or
  • Second-line or subsequent therapy for refractory or progressive disease in individuals with indications for treatment as a single agent (preferred**), or in combination with bendamustine or lenalidomide, or as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen; or
  • Consolidation as optional first-line extended therapy in individuals initially treated with single agent rituximab.

Histologic Transformation of Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

  • Treatment of individuals who have received minimal or no prior chemotherapy as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-dense RCHOP-14; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) and rituximab regimen; or
  • Treatment of individuals who have received minimal or no prior chemotherapy and have poor left ventricular function as a component of:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen; or
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine and prednisolone) regimen; or
  • Treatment of individuals who have received minimal or no prior chemotherapy and are very frail and for individuals greater than 80 years of age with comorbidities as a component of:
    • RCEPP regimen; or
    • RCDOP regimen; or
    • R-mini-CHOP regimen; or
    • RGCVP regimen; or
  • Subsequent therapy for individuals who have received multiple lines of chemoimmunotherapy for indolent or transformed disease as a single agent, in combination with bendamustine, or as a component of:
    • DHAP (dexamethasone, cisplatin, and cytarabine) regimen; or
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen; or
    • ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) regimen; or
    • GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin) regimen; or
    • GemOX (gemcitabine and oxaliplatin) regimen; or
    • ICE (ifosfamide, carboplatin, and etoposide) regimen; or
    • MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen; or
    • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen; or
    • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen with rituximab; or
    • Lenalidomide: or
    • Gemcitabine and vinorelbine.

Hairy Cell Leukemia

  • Used in individuals with indications for treatment in combination with:
    • Cladribine for relapse or refractory disease if pentostatin was used as initial therapy; or
    • Pentostatin for relapsed or refractory disease if cladribine was used as initial therapy; or
    • Vemurafenib for progression after therapy for relapsed/refractory disease; or
  • As a single agent in individuals with indications for treatment who are unable to receive purine analogs for:
    • Less than complete response following initial treatment with cladribine or pentostatin; or
    • Relapse within two (2) years of complete response.

Mantle Cell Lymphoma

  • Preferred** aggressive induction therapy for stage I-II disease that had a partial response, progression, or relapse after initial treatment with involved site radiation therapy alone, or for aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV TP53 mutation negative (Aggressive induction therapy followed by HDT/ASCR may not be appropriate for TP53 positive disease. Optimal treatment unknown.) disease in individuals who are candidates for high-dose therapy/autologous stem cell rescue (HDT/ASCR) as a component of:
    • RDHA + platinum (rituximab, dexamethasone, cytarabine) + carboplatin, cisplatin, or oxaliplatin regimen; or
    • Alternating RCHOP/RDHAP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)/(rituximab, dexamethasone, cytarabine, and cisplatin) regimen; or
    • HyperCVAD (rituximab, cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen with rituximab; or
    • NORDIC (dose-intensified induction immunochemotherapy with rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone [maxi-CHOP] alternating with rituximab and high-dose cytarabine) regimen; or
  • Aggressive induction therapy in combination with bendamustine for stage I-II disease that had a partial response, progression, or relapse after initial treatment with involved site radiation therapy alone, or for aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV TP53 mutation negative disease (Aggressive induction therapy followed by HDT/ASCR may not be appropriate for TP53 positive disease. Optimal treatment is unknown); or
  • Preferred** less aggressive induction therapy for stage I-II disease as initial therapy (localized presentation, extremely rare), or for partial response, progression, or relapse after initial treatment with involved site radiation therapy alone, or for aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV TP53 mutation positive disease in individuals who are not candidates for high dose therapy/autologous stem cell rescue in combination with bendamustine or lenalidomide, or as a component of:
    • VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) regimen; or
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen with rituximab; or
    • Modified HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) regimen with rituximab in individuals older than 65 years; or
  • Less aggressive induction therapy for stage I-II disease (localized presentation, extremely rare) as initial therapy, or for partial response, progression, or relapse after initial treatment with involved site radiation therapy alone, or for aggressive stage II bulky, III, or IV TP53 mutation positive disease, or symptomatic indolent stage II bulky, III, or IV disease in individuals who are not candidates for high-dose therapy/autologous stem cell rescue as a component of RBAC (rituximab, bendamustine, and cytarabine) regimen; or
  • Consider single-agent maintenance therapy for aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV disease following complete or partial response to less aggressive induction therapy (Prospective trial data suggests no benefit of maintenance therapy after bendamustine + rituximab and maintenance therapy following VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) or RBAC (rituximab, bendamustine and cytarabine) therapy has not been tested or high-dose therapy with autologous stem cell rescue; or
  • Second-line therapy for stage I-II disease or aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV disease to achieve a complete response following partial response to induction therapy, for relapsed or progressive disease:
    • In combination with ibrutinib or lenalidomide (preferred regimens**) following a short response duration to prior chemoimmunotherapy (less than expected median progression free survival (PFS)); or
    • In combination with ibrutinib following an extended response duration to prior chemoimmunotherapy (greater than expected median PFS); or
    • In combination with ibrutinib and lenalidomide; or
  • Second-line therapy for stage I-II disease, aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV disease to achieve a complete response following partial response to induction therapy or for relapsed or progressive disease following an extended response duration to prior chemoimmunotherapy (greater than expected median progression free survival) as a single agent, in combination with bendamustine or bortezomib, or as a component of:
    • PEPC (prednisone, etoposide, procarbazine, and cyclophosphamide) with rituximab regimen; or
    • Bendamustine, bortezomib, and rituximab regimen; or
    • Gemcitabine, vinorelbine and rituximab regimen; or
    • DHAP (dexamethasone, cisplatin, and cytarabine) regimen with rituximab; or
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) with rituximab regimen; or
    • ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) regimen with rituximab; or
    • GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin) regimen with rituximab; or
    • GemOX (gemcitabine and oxaliplatin) regimen with rituximab; or
    • ICE (ifosfamide, carboplatin, and etoposide) regimen with rituximab; or
    • MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen with rituximab; or
    • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen with rituximab; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab; or
    • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen with rituximab; or
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen (preferred regimen**, if not previously given); or
    • VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) regimen (preferred regimen**, if not previously given).

Post-transplant Lymphoproliferative Disorder (PTLD)

  • Single-agent therapy as:
    • First-line therapy for monomorphic (B-cell type) or polymorphic (B-cell type) PTLD; or
    • Second-line therapy for partial response, persistent or progressive early lesions or for partial response, persistent or progressive monomorphic (B-cell type) PTLD if immunosuppressive was reduced in first-line therapy; or
    • Maintenance therapy for polymorphic (B-cell type) PTLD achieving complete response on first-line therapy; or
  • Concurrent chemoimmunotherapy for CD20+ disease as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen with rituximab or as a component of CVP (cyclophosphamide, vincristine, and prednisone), CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine), or CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen with rituximab for frail individuals who cannot tolerate anthracyclines as:
    • First-line therapy for monomorphic (B-cell type) or systemic polymorphic PTLD; or
    • Second-line therapy for partial response, persistent or progressive monomorphic (B-cell type) or polymorphic (B-cell type) PTLD; or
  • Sequential chemoimmunotherapy as a single agent followed by CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen with or without rituximab as:
    • First-line therapy for monomorphic (B-cell type) or systemic polymorphic (B-cell type) PTLD; or
    • Second-line therapy for persistent or progressive monomorphic (B-cell type) or polymorphic (B-cell type) PTLD; or
  • Second-line and subsequent therapy for individuals with partial response, persistent or progressive disease after receiving chemoimmunotherapy as first-line treatment for monomorphic PTLD (B-cell type) as a single agent or in combination with:
    • Bendamustine; or
    • DHAP (dexamethasone, cisplatin, and cytarabine) regimen; or
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen; or
    • ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) regimen; or
    • GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin) regimen; or
    • GemOX (gemcitabine and oxaliplatin) regimen; or
    • ICE (ifosfamide, carboplatin, and etoposide) regimen; or
    • MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen; or
    • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen; or
    • Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen; or
    • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen with rituximab; or
    • Lenalidomide; or
    • Gemcitabine and vinorelbine.

Primary Cutaneous B-Cell Lymphoma

  • Therapy for generalized (skin only), T3 primary cutaneous marginal zone or follicle center lymphoma.

Immune Checkpoint Inhibitor-Related Toxicities

  • Treatment of immunotherapy-related encephalitis after viral causes have been excluded in individuals positive for autoimmune encephalopathy antibody, or who have had limited or no improvement after 7-14 days on pulse-dose methylprednisolone with or without intravenous immune globulin.

Splenic Marginal Zone Lymphoma

  • Preferred** therapy as a single-agent for symptomatic individuals with splenomegaly who have ONE of the following features:
    • Hepatitis C negative; or
    • Hepatitis C positive with contraindications for hepatitis treatment; or
    • Hepatitis C positive with no response to appropriate hepatitis treatment; or
  • Used as a single agent (preferred**) or in combination with chlorambucil or cyclophosphamide in elderly or infirm individuals with indications for treatment for disease recurrence following initial treatment for splenomegaly when tolerability of combination chemotherapy is a concern as:
    • First-line therapy; or
    • Second-line or subsequent therapy; or
  • Preferred** first-line therapy for disease recurrence following initial treatment for splenomegaly in individuals with indications for treatment as a single agent in combination with bendamustine, or as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen; or
  • Used in combination with lenalidomide as first-line therapy for disease recurrence following initial treatment for splenomegaly in individuals with indications for treatment; or
  • Consolidation as optional first-line extended therapy in individuals initially treated with single agent rituximab; or
  • Second-line (if prior treatment with rituximab) or subsequent therapy for disease recurrence in individuals with indications for treatment as a single agent or in combination with bendamustine or lenalidomide, or as a component of:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen; or
    • RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) regimen.

Waldenstrom’s Macroglobulinemia/Lymphoplasmacytic Lymphoma

  • Used as a component of CaRD (carfilzomib, rituximab, and dexamethasone) regimen:
    • As primary therapy; or
    • For relapse greater than or equal to 24 months if used as primary therapy; or
  • Used as primary therapy, as therapy for previously treated disease that does not respond to primary therapy, or for progressive or relapsed disease:
    • In combination with bendamustine (preferred regimen**); or
    • In combination with bortezomib and dexamethasone (preferred regimen**); or
    • In combination with cyclophosphamide and dexamethasone (preferred regimen**); or
    • As a single agent; or
    • In combination with bortezomib; or
    • In combination with cyclophosphamide and prednisone; or
    • As a component of CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab) regimen; or
    • In combination with cladribine or fludarabine in individuals who are not potential autologous stem cell transplant candidates; or
    • As a component of FCR (fludarabine, cyclophosphamide, and rituximab) regimen in individuals who are not potential autologous stem cell transplant candidates; or
    • In combination with ibrutinib (preferred therapy for previously treated disease that does not respond to primary therapy or for progressive or relapsed disease); or
  • Consider for maintenance therapy following a complete, very good partial, partial, or minor response to primary therapy if regimen included rituximab.

Acute Lymphoblastic Leukemia

  • Induction/consolidation therapy for Philadelphia chromosome-negative ALL in AYA and adult individuals as a component of:
    • GRAALL-2005 regimen (daunorubicin, vincristine, prednisone, pegaspargase, and cyclophosphamide) with rituximab for CD20-positive disease (individuals aged less than 60 years); or
    • HyperCVAD (hyper-fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone, alternating with high-dose methotrexate and cytarabine), with or without rituximab for CD20-positive disease; or
  • Induction therapy for Philadelphia chromosome-negative ALL in adults aged greater than or equal to 65 years as a component of GMALL (idarubicin, dexamethasone, vincristine, cyclophosphamide, and cytarabine, with or without rituximab for CD20-positive disease) (moderate intensity); or
  • Therapy for relapsed/refractory Philadelphia chromosome-negative ALL or for relapsed/refractory Philadelphia chromosome-positive ALL refractory to TKIs as a component of MOpAD regimen (methotrexate, vincristine, pegaspargase, dexamethasone) with rituximab for CD20-positive disease; or
  • Therapy for relapsed/refractory Philadelphia chromosome-positive ALL as a component of MOpAD regimen (methotrexate, vincristine, pegaspargase, dexamethasone) with rituximab for CD20-positive disease and TKI.

The use of rituximab (Rituxan) for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes

J9312

Rituximab and hyaluronidase human (Rituxan Hycela ) subcutaneous (SC) healthcare administered

FDA Approved Indications

Rituximab and hyaluronidase human (Rituxan Hycela) may be considered medically necessary for adult individuals 18 years of age and older only after individual has received at least one full dose of rituximab (Rituxan) by intravenous infusion for ANY of the following indications:

Chronic lymphoid leukemia (CLL)

  • Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC).

DLBCL

  • Previously untreated DLBCL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

Follicular lymphoma (FL)

  • Relapsed or refractory, follicular lymphoma as a single agent; or
  • Previously untreated follicular lymphoma in combination with first line chemotherapy and, in individuals achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy; or
  • Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

Individuals receiving rituximab and hyaluronidase human (Rituxan Hycela) cannot receive a live vaccination at least four (4) weeks prior to or during treatment with rituximab and hyaluronidase human (Rituxan Hycela).

The use of rituximab and hyaluronidase human (Rituxan Hycela) for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes

J9311

NCCN Approved Indications

Rituximab and hyaluronidase human (Rituxan Hycela) may be considered medically necessary for adult individuals 18 years of age and older for ANY of the following indications:

Primary Cutaneous B-Cell Lymphomas

  • May be substituted for rituximab after individuals have received the first full dose of rituximab by intravenous infusion as therapy for generalized disease (skin only), T3 primary cutaneous marginal zone or follicle center lymphoma.

Follicular Lymphoma (grade 1-2)

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies (except ibritumomab tiuxetan) after individuals have received the first full dose of rituximab by intravenous infusion.

Gastric MALT Lymphoma

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies (except ibritumomab tiuxetan) after individuals have received the first full dose of rituximab by intravenous infusion.

Nongastric MALT Lymphoma

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies (except ibritumomab tiuxetan) after individuals have received the first full dose of rituximab by intravenous infusion.

Nodal Marginal Zone Lymphoma

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies (except ibritumomab tiuxetan) after individuals have received the first full dose of rituximab by intravenous infusion.

Splenic Marginal Zone Lymphoma

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies (except ibritumomab tiuxetan) after individuals have received the first full dose of rituximab by intravenous infusion.

Histologic Transformation of Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies (except for ibritumomab tiuxetan) after individuals have received the first full dose of rituximab by intravenous infusion.

Mantle Cell Lymphoma

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies after individuals have received the first full dose of rituximab by intravenous infusion.

Diffuse Large B-Cell Lymphoma

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies (except ibritumomab tiuxetan) after individuals have received the first full dose of rituximab by intravenous infusion.

AIDS-Related B-Cell Lymphomas

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies after individuals have received the first full dose of rituximab by intravenous infusion.

Burkitt Lymphoma

  • May be substituted for rituximab in combination with other systemic therapies after individuals have received the first full dose of rituximab by intravenous infusion.

Post-Transplant Lymphoproliferative Disorders

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies after individuals have received the first full dose of rituximab by intravenous infusion.

Castleman’s Disease (CD)

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies after individuals have received the first full dose of rituximab by intravenous infusion.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies in individuals who have received at least one full dose of a rituximab product by intravenous route.

High-Grade B-Cell Lymphomas

  • May be substituted for rituximab as a single agent or in combination with other systemic therapies after individuals have received the first full dose of rituximab by intravenous infusion.

Individuals receiving rituximab and hyaluronidase human (Rituxan Hycela) cannot have a live vaccination prior to or during treatment with rituximab and hyaluronidase human (Rituxan Hycela).

The use of rituximab and hyaluronidase human (Rituxan Hycela) for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes

J9311

Rituximab-abbs (Truxima) may be considered medically necessary for the treatment of adults for ANY of the following indications:

Non-Hodgkin's Lymphoma (NHL)

  • Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent; or
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in individuals achieving a complete or partial response to a rituximab product in combination with chemotherapy, as a single agent maintenance therapy; or
  • Non-progressive (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

The use of rituximab-abbs (Truxima) for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes

Q5115

*Maintenance rituximab is not appropriate after bendamustine and rituximab therapy and has not been tested after VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) or RBAC (rituximab, bendamustine and cytarabine) therapy.

**Note: Language derived from National Comprehensive Cancer Network (NCCN) guidelines.

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J9312

C79.32 C81.00 C81.01 C81.02 C81.03 C81.04 C81.05
C81.06 C81.07 C81.08 C81.09 C82.00 C82.01 C82.02
C82.03 C82.04 C82.05 C82.06 C82.07 C82.08 C82.09
C82.10 C82.11 C82.12 C82.13 C82.14 C82.15 C82.16
C82.17 C82.18 C82.19 C82.20 C82.21 C82.22 C82.23
C82.24 C82.25 C82.26 C82.27 C82.28 C82.29 C82.30
C82.31 C82.32 C82.33 C82.34 C82.35 C82.36 C82.37
C82.38 C82.39 C82.40 C82.41 C82.42 C82.43 C82.44
C82.45 C82.46 C82.47 C82.48 C82.49 C82.60 C82.61
C82.62 C82.63 C82.64 C82.65 C82.66 C82.67 C82.68
C82.69 C82.80 C82.81 C82.82 C82.83 C82.84 C82.85
C82.86 C82.87 C82.88 C82.89 C82.90 C82.91 C82.92
C82.93 C82.94 C82.95 C82.96 C82.97 C82.98 C82.99
C83.00 C83.01 C83.02 C83.03 C83.04 C83.05 C83.06
C83.07 C83.08 C83.09 C83.10 C83.11 C83.12 C83.13
C83.14 C83.15 C83.16 C83.17 C83.18 C83.19 C83.30
C83.31 C83.32 C83.33 C83.34 C83.35 C83.36 C83.37
C83.38 C83.39 C83.50 C83.51 C83.52 C83.53 C83.54
C83.55 C83.56 C83.57 C83.58 C83.59 C83.70 C83.71
C83.72 C83.73 C83.74 C83.75 C83.76 C83.77 C83.78
C83.79 C83.80 C83.81 C83.82 C83.83 C83.84 C83.85
C83.86 C83.87 C83.88 C83.89 C85.10 C85.11 C85.12
C85.13 C85.14 C85.15 C85.16 C85.17 C85.18 C85.19
C85.20 C85.21 C85.22 C85.23 C85.24 C85.25 C85.26
C85.27 C85.28 C85.29 C85.80 C85.81 C85.82 C85.83
C85.84 C85.85 C85.86 C85.87 C85.88 C85.89 C88.0
C88.4 C91.00 C91.01 C91.02 C91.10 C91.12 C91.40
C91.42 D36.0 D47.Z1 D47.Z2 D59.0 D59.1 D66
D69.3 D69.41 D69.42 D69.49 D89.1 D89.811 G04.81
G35 G36.0 G37.0 G37.5 G60.8 G61.89 G62.89
G64 L10.0 L10.1 L10.2 L10.3 L10.4 L10.5
L10.81 L10.89 L12.0 L12.1 L12.2 L12.31 L12.35
L12.8 M05.011 M05.012 M05.021 M05.022 M05.031 M05.032
M05.041 M05.042 M05.051 M05.052 M05.061 M05.062 M05.071
M05.072 M05.09 M05.111 M05.112 M05.121 M05.122 M05.131
M05.132 M05.141 M05.142 M05.151 M05.152 M05.161 M05.162
M05.171 M05.172 M05.19 M05.211 M05.212 M05.221 M05.222
M05.231 M05.232 M05.241 M05.242 M05.251 M05.252 M05.261
M05.262 M05.271 M05.272 M05.29 M05.311 M05.312 M05.321
M05.322 M05.331 M05.332 M05.341 M05.342 M05.351 M05.352
M05.361 M05.362 M05.371 M05.372 M05.39 M05.411 M05.412
M05.421 M05.422 M05.431 M05.432 M05.441 M05.442 M05.451
M05.452 M05.461 M05.462 M05.471 M05.472 M05.49 M05.511
M05.512 M05.521 M05.522 M05.531 M05.532 M05.541 M05.542
M05.551 M05.552 M05.561 M05.562 M05.571 M05.572 M05.59
M05.611 M05.612 M05.621 M05.622 M05.631 M05.632 M05.641
M05.642 M05.651 M05.652 M05.661 M05.662 M05.671 M05.672
M05.69 M05.711 M05.712 M05.721 M05.722 M05.731 M05.732
M05.741 M05.742 M05.751 M05.752 M05.761 M05.762 M05.771
M05.772 M05.79 M05.811 M05.812 M05.821 M05.822 M05.831
M05.832 M05.841 M05.842 M05.851 M05.852 M05.861 M05.862
M05.871 M05.872 M05.89 M05.9 M06.011 M06.012 M06.021
M06.022 M06.031 M06.032 M06.041 M06.042 M06.051 M06.052
M06.061 M06.062 M06.071 M06.072 M06.08 M06.09 M06.1
M06.211 M06.212 M06.221 M06.222 M06.231 M06.232 M06.241
M06.242 M06.251 M06.252 M06.262 M06.271 M06.272 M06.28
M06.29 M06.311 M06.312 M06.321 M06.322 M06.331 M06.332
M06.341 M06.342 M06.351 M06.352 M06.361 M06.362 M06.371
M06.372 M06.38 M06.39 M06.811 M06.812 M06.821 M06.822
M06.831 M06.832 M06.841 M06.842 M06.851 M06.852 M06.861
M06.862 M06.871 M06.872 M06.88 M06.89 M06.9 M30.0
M30.1 M30.2 M30.8 M31.1 M31.30 M31.31 M31.7
M32.0 M32.10 M32.11 M32.12 M32.13 M32.14 M32.15
M32.19 M32.8 M32.9 M33.20 M33.21 M33.22 M33.29
M34.0 M34.1 M34.2 M34.81 M34.82 M34.83 M34.9
M35.00 M35.01 M35.02 M35.03 M35.04 M35.09 R59.0
R59.1 R59.9 Z85.71 Z85.72 Z85.79

 

Primary Diagnosis code B20 must be billed with one of the following for J9312

C83.30 C83.31 C83.32 C83.33 C83.34 C83.35 C83.36
C83.37 C83.38 C83.39 C83.70 C83.71 C83.72 C83.73
C83.74 C83.75 C83.76 C83.77 C83.78 C83.79 C83.90
C83.91 C83.92 C83.93 C83.94 C83.95 C83.96 C83.97
C83.98 C83.99 C85.80 C85.81 C85.82 C85.83 C85.84
C85.85 C85.86 C85.87 C85.88 C85.89 Z85.79

 

Covered Diagnosis Codes for Procedure Code J9311

C82.00 C82.01 C82.02 C82.03 C82.04 C82.05 C82.06
C82.07 C82.08 C82.09 C82.10 C82.11 C82.12 C82.13
C82.14 C82.15 C82.16 C82.17 C82.18 C82.19 C82.20
C82.21 C82.22 C82.23 C82.24 C82.25 C82.26 C82.27
C82.28 C82.29 C82.30 C82.31 C82.32 C82.33 C82.34
C82.35 C82.36 C82.37 C82.38 C82.39 C82.40 C82.41
C82.42 C82.43 C82.44 C82.45 C82.46 C82.47 C82.48
C82.49 C82.50 C82.51 C82.52 C82.53 C82.54 C82.55
C82.56 C82.57 C82.58 C82.59 C82.60 C82.61 C82.62
C82.63 C82.64 C82.65 C82.66 C82.67 C82.68 C82.69
C82.80 C82.81 C82.82 C82.83 C82.84 C82.85 C82.86
C82.87 C82.88 C82.89 C82.90 C82.91 C82.92 C82.93
C82.94 C82.95 C82.96 C82.97 C82.98 C82.99 C83.00
C83.01 C83.02 C83.03 C83.04 C83.05 C83.06 C83.07
C83.08 C83.09 C83.10 C83.11 C83.12 C83.13 C83.14
C83.15 C83.16 C83.17 C83.18 C83.19 C83.30 C83.31
C83.32 C83.33 C83.34 C83.35 C83.36 C83.37 C83.38
C83.39 C83.70 C83.71 C83.72 C83.73 C83.74 C83.75
C83.76 C83.77 C83.78 C83.79 C83.80 C83.81 C83.82
C83.83 C83.84 C83.85 C83.86 C83.87 C83.88 C83.89
C85.20 C85.21 C85.22 C85.23 C85.24 C85.25 C85.26
C85.27 C85.28 C85.29 C85.80 C85.81 C85.82 C85.83
C85.84 C85.85 C85.86 C85.87 C85.88 C85.89 C88.4
C91.10 C91.12 D36.0 D47.Z1 D47.Z2 R59.0 R59.1
R59.9 Z85.72

 

Primary Diagnosis code B20 must be billed with one of the following for J9311

C83.30 C83.31 C83.32 C83.33 C83.34 C83.35 C83.36
C83.37 C83.38 C83.39 C83.80 C83.81 C83.82 C83.83
C83.84 C83.85 C83.86 C83.87 C83.88 C83.89 C83.90
C83.91 C83.92 C83.93 C83.94 C83.95 C83.96 C83.97
C83.98 C83.99 C85.80 C85.81 C85.82 C85.83 C85.84
C85.85 C85.86 C85.87 C85.88 C85.89

 

Covered Diagnosis Codes for Q5115

C85.80 C85.81 C85.82 C85.83 C85.84 C85.85 C85.86
C85.87 C85.88 C85.89 C85.90 C85.91 C85.92 C85.93
C85.94 C85.95 C85.96 C85.97 C85.98 C85.99

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