HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-38-032
Topic:
Rituximab (Rituxan), Rituximab Biosimilars, and Rituximab and Hyaluronidase Human (Rituxan Hycela)
Section:
Injections
Effective Date:
October 1, 2023
Issued Date:
October 1, 2023
Last Revision Date:
September 2023
Annual Review:
July 2022
 
 

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 percent 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®), rituximab-arrx (Riabni™), and rituximab-pvvr (Ruxience™) are biosimilars of rituximab (Rituxan).

Policy Position

Preferred Products

Rituximab-arrx (Riabni) and rituximab-pvvr (Ruxience) are the preferred rituximab biosimilars for individuals initiating new therapy for oncologic indications when the clinical criteria within this policy are met. A non-preferred product will be considered when the individual has a documented therapy failure after an adequate therapeutic trial of a preferred product, or the preferred product has not been tolerated or is contraindicated.

Rituximab-arrx (Riabni) and rituximab-pvvr (Ruxience) are the preferred rituximab biosimilars for Rheumatoid Arthritis (RA) indications when the clinical criteria within this policy are met. A non-preferred product will be considered when the individual has a documented therapy failure after an adequate therapeutic trial of a preferred product, or the preferred product has not been tolerated or is contraindicated.

Adequate therapeutic trial is defined as 180 days from first dose of therapy at Food and Drug Administration (FDA) or compendia based therapeutic doses of preferred product.

New therapy is defined as no previous utilization within the last 180 calendar days.

Q5119

Q5123

 

 

 

 

 




Rituximab (Rituxan)

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

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

  • Treatment of individuals with antineutrophil cytoplasmic antibody‒associated vasculitides (i.e., granulomatosis with polyangiitis (GPA) [Wegener granulomatosis] and microscopic polyangiitis), in combination with glucocorticoids; or

Chronic Lymphocytic Leukemia (CLL)

  • Treatment of previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC); or

Non-Hodgkin’s Lymphoma (NHL)

Treatment of NHL in any of the following:

  • 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 rituximab (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; or

Pemphigus Vulgaris (PV)

  • Treatment of moderate to severe treatment-refractory PV in individuals 18 years or older; or

Rheumatoid Arthritis (RA)

  • Treatment of individuals 18 years of age or older with RA who meet the following criteria:
    • RA is moderately to severely active (e.g., greater than or equal to eight (8) swollen and tender joints); and
    • Rituximab (Rituxan) is administered in combination with methotrexate, or other conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if methotrexate is contraindicated; and
      • Individual has had an inadequate response to one (1) or more tumor necrosis factor inhibitors, or is not suitable for treatment with tumor necrosis factor inhibitors; or
      • Combination therapy with methotrexate or other conventional synthetic DMARD not applicable to individuals who have had an inadequate response to methotrexate or other conventional synthetic DMARDs.

Compendia Sources
Rituximab (Rituxan) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations

Reauthorization Criteria for rituximab (Rituxan)

Continuation of therapy with rituximab (Rituxan) for non-oncologic indications may be considered medically necessary when the following criteria is met: 

  • The individual has one of the above diagnoses; and
  • For RA only; the individual has had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to the preferred product; and
  • Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and
  • Reauthorization valid for 12 months.

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.

J9312

 

 

 

 

 

 

 




Other clinically supported indications

Rituximab (Rituxan) may be considered medically necessary for ANY of the following 2b or higher off-label indications:

Autoimmune Hemolytic Anemia (AIHA)

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

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; or

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

  • Prophylaxis for Epstein Barr virus infection in pediatric individuals undergoing hematopoietic stem cell transplant; or

Evans syndrome (Pediatric only)

  • Treatment for Evans syndrome refractory to immunosuppressive therapy; or

Hemophilia

  • Treatment of individuals 18 years of age or older for hemophilia with acquired inhibitors in individuals who are refractory to conventional first line treatments (i.e. immunosuppression with prednisone and cyclophosphamide); or

Hepatitis C Virus‒Associated Cryoglobulinemic Vasculitis

  • As add-on therapy for individuals with hepatitis C virus‒associated cryoglobulinemic vasculitis who have:
    • Active disease resistant to antiviral drugs; or
    • Severe or life-threatening cryoglobulinemic vasculitis; or

Idiopathic Membranous Nephropathy

  • As treatment for idiopathic membranous nephropathy; or

Immune thrombocytopenia, previously treated (Pediatric only)

  • Treatment for pediatric individuals with previously treated primary and secondary immune thrombocytopenia; or

Inflammatory Myopathy (Idiopathic)

  • Treatment for individuals 18 years of age or older who have failed to respond to, or are intolerant to, another immunosuppressant (e.g. methotrexate) with refractory idiopathic inflammatory myopathy; or

Lupus Nephritis

  • As add-on therapy for lupus nephritis refractory to standard first-line treatment regimen; or

Microscopic polyarteritis nodosa (Adult only)

  • treatment for microscopic polyarteritis nodosa in combination with glucocorticoids; or

Minimal change disease (Pediatric only)

  • Treatment for remission induction and maintenance of remission in pediatric individuals who have refractory, steroid-dependent or steroid-resistant minimal change disease; or

Multiple Sclerosis (Primary Progressive)

  • Treatment for individuals 18 years of age or older with primary progressive multiple sclerosis who have gadolinium brain lesions at baseline and have failed treatment with ocrelizumab; or

Multiple Sclerosis (Relapsing Remitting)

  • Treatment of relapsing remitting multiple sclerosis when the individuals has experienced therapeutic failure, intolerance, or contraindication to two (2) alternative drug therapies indicated for the treatment of multiple sclerosis (e.g. Avonex, Aubagio, Gilenya, etc.); or   

Myasthenia Gravis

  • Treatment for individuals 18 years of age or older with myasthenia gravis refractory to conventional therapy (e.g., azathioprine, corticosteroids, immunosuppressants, plasma exchange, IV immunoglobulin, thymectomy); or

Myopathy, Idiopathic Inflammatory

  • Treatment for refractory idiopathic inflammatory myopathy in individuals who have failed to respond to, or are intolerant to, another immunosuppressant (e.g. methotrexate); or

Neuromyelitis Optica

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

Pemphigoid Diseases

  • 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; or

Pemphigus Diseases

  • Treatment for pemphigus diseases (i.e., pemphigus vulgaris, paraneoplastic pemphigus); or

Pemphigus Foliaceus

  • Treatment for individuals 18 years of age or older with pemphigus foliaceus in combination with a tapering course of corticosteroids; or

Sjögren’s Syndrome (Primary)

  • Treatment for individuals 18 years of age or older with primary Sjögren’s syndrome as a one (1) time course of treatment over 15 days; or

Systemic Lupus Erythematosus

  • Treatment as add-on therapy for systemic lupus erythematosus refractory to immunosuppressive therapy; or

Systemic Sclerosis (Scleroderma)

  • Treatment for systemic sclerosis (scleroderma) in individuals refractory to first-line treatment; or

Thrombocytopenic purpura (Idiopathic)

  • Treatment for individuals 18 years of age or older with idiopathic thrombocytopenic purpura refractory to first-line therapy (e.g., corticosteroids, IV immune globulin, splenectomy, etc.) who are at risk of bleeding (grade 2C); or

Thrombotic Thrombocytopenic Purpura

  • Treatment in combination with steroids and plasma exchange in individuals 18 years of age or older with refractory thrombotic thrombocytopenic purpura (i.e., lack of response to plasma exchange therapy and glucocorticoids).

Reauthorization Criteria for rituximab (Rituxan)

Continuation of therapy with rituximab (Rituxan) for non-oncologic indications may be considered medically necessary when the following criteria is met:

  • The individual has one of the above diagnoses; and
  • For RA only; the individual has had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to the preferred product; and
  • Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and
  • Reauthorization valid for 12 months.

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.

J9312

 

 

 

 

 

 

 




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

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 a rituximab product 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); or

Diffuse Large B-Cell Lymphoma (DLBCL)

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

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 (Rituxan) 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; or

Compendia Sources
Rituximab and hyaluronidase human (Rituxan Hycela®) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations

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.

J9311

 

 

 

 

 

 

 




Rituximab-abbs (Truxima) or rituximab-pvvr (Ruxience) may be considered medically necessary for the treatment of individuals 18 years and older for ANY of the following indications: 

Chronic Lymphocytic Leukemia (CLL)

  • For previously untreated or previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide; or

Granulomatosis with Polyangitis, Wegener’s Granulomatosis, and Microscopic Polyangiitis

  • As therapy in combination with glucocorticoids; or

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; or
  • Previously untreated DLBCL, CD20-positive NHL in combination with CHOP or anthracycline-based chemotherapy regimens; or

Rheumatoid Arthritis (RA)

  • As therapy in combination with methotrexate, or other conventional synthetic DMARD if methotrexate is contraindicated, for moderately-to-severely-active RA who have had an inadequate response to one or more TNF antagonist therapies:
    • Combination therapy with methotrexate or other conventional synthetic DMARD not applicable to individuals who have had an inadequate response to methotrexate or other conventional synthetic DMARDs

 

Compendia Sources

Rituximab-abbs (Truxima) or rituximab-pvvr (Ruxience) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

Reauthorization Criteria for Rituximab-abbs (Truxima) or Rituximab-pvvr (Ruxience)

Continuation of therapy with rituximab-abbs (Truxima) or rituximab-pvvr (Ruxience) for non-oncologic indications may be considered medically necessary when the following criteria is met:

  • The individual has one of the above diagnoses; and
  • For RA only; individual has had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to the preferred product; and
  • Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and
  • Reauthorization valid for 12 months.

The use of rituximab-abbs (Truxima) or rituximab-pvvr (Ruxience) 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. 

Q5115

 Q5119

 

 

 

 

 

 




Rituximab-arrx (Riabni) may be considered medically necessary for the treatment of individuals 18 years and older for ANY of the following indications: 

Chronic Lymphocytic Leukemia (CLL)

  • For previously untreated or previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide; or

Granulomatosis with Polyangitis, Wegener’s Granulomatosis, and Microscopic Polyangiitis

  • As therapy in combination with glucocorticoids; or

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; or
  • Previously untreated DLBCL, CD20-positive NHL in combination with CHOP or anthracycline-based chemotherapy regimens; or

Rheumatoid Arthritis (RA)

  • As therapy in combination with methotrexate, or other conventional synthetic DMARD if methotrexate is contraindicated, for moderately-to-severely-active RA who have had an inadequate response to one or more TNF antagonist therapies:
    • Combination therapy with methotrexate or other conventional synthetic DMARD not applicable to individuals who have had an inadequate response to methotrexate or other conventional synthetic DMARDs.

Compendia Sources
Rituximab-arrx (Riabni) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations

Reauthorization Criteria for rituximab-arrx (Riabni) 

Continuation of therapy with rituximab-arrx (Riabni) for non-oncologic indications may be considered medically necessary when the following criteria is met:

  • The individual has one of the above diagnoses; and
  • For RA only; individual has had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to the preferred product; and
  • Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and
  • Reauthorization valid for 12 months.

The use of rituximab-arrx (Riabni) 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.

Q5123

 

 

 

 

 

 




*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: 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.


Related Policies

Refer to medical policy I-25 Desensitization Treatment for Heart and Renal Transplant for additional information.

Refer to Medical Policy I-249 Pennsylvania Cancer Treatment Mandate, for additional information.


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

C82.50

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

C83.50

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

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

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

D59.10

D59.11

D59.12

D59.13

D59.19

D66

D69.3

D69.41

D69.42

D69.49

D89.811

D89.812

D89.813

G04.81

G35

G36.0

G37.0

G37.5

G37.81

G37.89

G60.8

G61.89

G62.89

G64

G70.00

G70.01

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

L13.8

L13.9

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

M33.90

M33.91

M33.92

M33.93

M33.99

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

N01.0

N01.1

N01.2

N02.0

N02.1

N02.2

N02.3

N02.5

N02.8

N02.9

N02.B1

N02.B2

N02.B3

N02.B4

N02.B5

N02.B6

N02.B9

N03.0

N03.2

N04.0

N04.1

N04.20

N04.21

N04.22

N04.29

N04.3

N04.4

N04.5

N04.6

N04.7

N04.8

N04.9

N05.0

N05.2

N07.0

N07.1

N07.2

N08

R59.0

R59.1

R59.9

T86.09

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

C83.80

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

C91.40

C91.42

D36.0

D47.Z1

D47.Z2

R59.0

R59.1

R59.9

 

 

 

Covered Diagnosis Codes for Q5115

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

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

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

C88.4

C91.10

C91.40

C91.42

D36.0

D47.Z1

D47.Z2

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

M31.30

M31.31

M31.7

R59.0

R59.1

R59.9

 

 

 

 

 

  Covered Diagnosis Codes for Q5119

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

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

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

C88.4

C91.10

D36.0

D47.Z1

D47.Z2

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

M05.711

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

M05.811

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

M05.9

M06.00

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

M31.30

M31.31

M31.7

R59.0

R59.1

R59.9

Covered Diagnosis Codes for Q5123

 

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

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

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

C88.4

C91.10

C91.40

C91.42

D36.0

D47.Z1

D47.Z2

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

M05.711

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

M05.811

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

M05.9

M06.00

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

M31.30

M31.31

M31.7

R59.0

R59.1

R59.9

 

 

 

 

 



Place of Service: Outpatient

The administration of Rituximab (Rituxan), rituximab biosimilars, and Rituximab and Hyaluronidase Human (Rituxan Hycela) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.