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Rituxan Hycela® (rituximab and hyaluronidase human)

Policy Number: VP-90322

(Subcutaneous)

 

Last Review Date: 03/05/2024

Date of Origin: 7/20/2010

Dates Reviewed: 09/2010, 12/2010, 02/2011, 03/2011, 05/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 10/2016, 02/2017, 05/2017, 08/2017, 10/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 03/2021, 03/2022, 03/2023, 03/2024

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization 1,7-11

Coverage will be provided for 6 months and may be renewed, unless otherwise specified.

  • Maintenance therapy for Mantle Cell Lymphoma may be renewed until disease progression or intolerable toxicity.
  • Hairy Cell Leukemia may be renewed up to a maximum of 11 total doses.
  • Maintenance therapy for all other indications may be renewed for up to a maximum of 2 years.
  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Rituxan Hycela 1,400 mg/23,400 Units per 11.7 mL single-dose vial:

4 vials per 28 day supply

  • Rituxan Hycela 1,600 mg/26,800 Units per 13.4 mL single-dose vial:

1 vial per 28 day supply

  1. Max Units (per dose and over time) [HCPCS Unit]:

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

  • 1,600 mg/26,800 U (160 billable units) every 28 days x 5 doses; OR
  • 1,600 mg/26,800 U (160 billable units) every 8 weeks (maintenance treatment)

Hairy Cell Leukemia

  • 1,400 mg/23,400 U (140 billable units) weekly up x 7 doses; OR
  • 1,400 mg/23,400 U (140 billable units) every 14 days x 7 doses, then every 28 days x 4 doses

All other indications:

  • 1,400 mg/23,400 U (140 billable units) weekly for x 7 doses in a 6-month period; OR
  • 1,400 mg/23,400 U (140 billable units) every 8 weeks (maintenance treatment)

  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

For PEEHIP Members Only

  • Ruxience (rituxumab-pvvr) and Truxima (rituximab-abbs) are the preferred products and all other rituximab products are non-preferred. Patients must have tried and had an inadequate response or intolerance to, or a contraindication to both the preferred products, attributable to the biosimilar formulation, prior to consideration of a non-preferred rituximab product; OR patient is continuing treatment with a non-preferred rituximab product for an oncology indication; AND

For Commercial Members Only

  • Ruxience (rituxumab-pvvr) and Truxima (rituximab-abbs) are the preferred products. Patient must have tried and had an inadequate response or intolerance to, or a contraindication to Ruxience and Truxima attributable to the biosimilar formulation, prior to consideration of a non-preferred rituximab product including Rituxan Hycela (rituximab and hyaluronidase human) OR Patient is continuing treatment with Rituxan Hycela; AND

  • Patient is at least 18 years of age; AND
  • Patient has received at least one full dose of a rituximab product by intravenous infusion prior to initiating therapy; AND

Universal Criteria 1

  • Patient does not have a severe, active infection; AND
  • Patient has been screened for the presence of hepatitis B virus (HBV) infection (i.e., HBsAg and anti-HBc) prior to initiating therapy and patients with evidence of current or prior HBV infection will be monitored for HBV reactivation during treatment; AND
  • Patient is CD20 antigen expression positive; AND
  • Rituxan Hycela will not be used with intravenous chemotherapy agents or ibritumomab tiuxetan radioimmunotherapy; AND
  • Patient has not received a live vaccine within 28 days prior to starting treatment and live vaccines will not be administered concurrently while on treatment; AND

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) † Ф 1,2

B-Cell Lymphomas † ‡ 1,2,6

  • Follicular Lymphoma (FL) Ф
  • Diffuse Large B-Cell Lymphoma (DLBCL)Ф
  • High-Grade B-Cell Lymphomas
  • Extranodal Marginal Zone Lymphoma (EMZL) of the Stomach & Nongastric Sites (Noncutaneous)
  • Nodal & Splenic Marginal Zone Lymphoma
  • Mantle Cell Lymphoma
  • Histologic Transformation of Indolent Lymphomas to Diffuse Large B-Cell Lymphoma
  • Post-Transplant Lymphoproliferative Disorders (PTLD)

Castleman Disease ‡ 2

Hairy Cell Leukemia ‡ 2,12

Primary Cutaneous B-Cell Lymphoma ‡ 2

Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma ‡ 2

Adult Hodgkin Lymphoma ‡ 2,3

  • Patient has nodular lymphocyte-predominant disease

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria 1,2,7-11

Coverage may be renewed based upon the following criteria:

  • Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity or other administration reactions (e.g., local cutaneous reactions), tumor lysis syndrome (TLS), severe mucocutaneous reactions (e.g., paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, etc.), progressive multifocal leukoencephalopathy (PML), hepatitis B virus reactivation, serious infections (bacterial, fungal or viral), cardiac adverse reactions, renal toxicity, bowel obstruction and perforation, etc.; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Patient has not exceeded dosing or duration limits as defined in Sections I, II, and V
  1. Dosage/Administration 1,3,7-12

Indication

Dose

CLL/SLL

1,600 mg/26,800 Units subcutaneously, at a fixed dose, irrespective of patient’s BSA.

  • Administer on Day 1 of Cycles 2–6 (every 28 days) for a total of 5 cycles (i.e., 6 cycles in total); OR
  • Administer once every 8 weeks (maintenance treatment)

Hairy Cell Leukemia

1,400 mg/23,400 Units subcutaneously, at a fixed dose, irrespective of patient’s BSA.

  • Administer once weekly for 3-7 doses; OR
  • Administer on day 15 of cycle 1 (28 day cycle), then on days 1 and 15 every 28 days for 3 cycles, then once every 28 days for 4 cycles (i.e., up to 8 total cycles or 11 total doses).

All other indications

1,400 mg/23,400 Units subcutaneously, at a fixed dose, irrespective of patient’s BSA.

  • Administer up to once weekly for 3-7 doses in a 6-month period; OR
  • Administer once every 8 weeks (maintenance treatment)

Note: Must be administered by a healthcare provider.

  1. Billing Code/Availability Information

HCPCS Code:

  • J9311 – Injection, rituximab 10 mg and hyaluronidase: 1 billable unit = 10 mg

NDC(s):

  • Rituxan Hycela 1,400 mg rituximab/23,400 Units hyaluronidase human per 11.7 mL single-dose vial: 50242-0108-xx
  • Rituxan Hycela 1,600 mg rituximab/26,800 Units hyaluronidase human per 13.4 mL single-dose vial: 50242-0109-xx
  1. References
  1. Rituxan Hycela [package insert]. South San Francisco, CA; Genentech, Inc.; June 2021. Accessed January 2024.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) rituximab and hyaluronidase human. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2024.
  3. Davies A, Merli F, Mihaljević B, et al. Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol. 2017 Jun;4(6):e272-e282. Doi: 10.1016/S2352-3026(17)30078-9. Epub 2017 May 2.
  4. Lugtenburg P, Avivi I, Berenschot H, et al. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica. 2017 Nov;102(11):1913-1922. Doi: 10.3324/haematol.2017.173583. Epub 2017 Sep 21.
  5. Assouline S, Buccheri V, Delmer A, et al. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol. 2016 Mar;3(3):e128-38. Doi:10.1016/S2352-3026(16)00004-1.
  6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas, Version 1.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed January 2024.
  7. Thomas DA, O'Brien S, Bueso-Ramos C, et al. Rituximab in relapsed or refractory hairy cell leukemia. Blood. 2003 Dec 1;102(12):3906-11. doi: 10.1182/blood-2003-02-0630.
  8. Nieva J, Bethel K, Saven A. Phase 2 study of rituximab in the treatment of cladribine-failed patients with hairy cell leukemia. Blood. 2003 Aug 1;102(3):810-3.
  9. Chihara D, Kantarjian H, O'Brien S, et al. Long-term durable remission by cladribine followed by rituximab in patients with hairy cell leukaemia: update of a phase II trial. Br J Haematol. 2016 Sep;174(5):760-6.
  10. Else M, Dearden CE, Matutes E, et al. Rituximab with pentostatin or cladribine: an effective combination treatment for hairy cell leukemia after disease recurrence. Leuk Lymphoma. 2011 Jun;52 Suppl 2:75-8. doi: 10.3109/10428194.2011.568650.
  11. Zenhäusern R, Simcock M, Gratwohl A, et al; Swiss Group for Clinical Cancer Research (SAKK). Rituximab in patients with hairy cell leukemia relapsing after treatment with 2-chlorodeoxyadenosine (SAKK 31/98). Haematologica. 2008 Sep;93(9):1426-8.
  12. Tiacci E, De Carolis L, Santi A, Falini B. Venetoclax in relapsed or refractory hairy-cell leukemia. N Engl J Med 2023;388:952-954.
  13. Palmetto GBA. Local Coverage Article: Billing and Coding: Rituximab (A56380). Centers for Medicare & Medicaid Services, Inc. Updated on 08/11/2023 with effective date of 10/01/2023. Accessed January 2024.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

 

C81.00

Nodular lymphocyte predominant Hodgkin lymphoma, unspecified site

C81.01

Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.02

Nodular lymphocyte predominant Hodgkin lymphoma, intrathoracic lymph nodes

C81.03

Nodular lymphocyte predominant Hodgkin lymphoma, intra-abdominal lymph nodes

C81.04

Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.05

Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.06

Nodular lymphocyte predominant Hodgkin lymphoma, intrapelvic lymph nodes

C81.07

Nodular lymphocyte predominant Hodgkin lymphoma, spleen

C81.08

Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of multiple sites

C81.09

Nodular lymphocyte predominant Hodgkin lymphoma, extranodal and solid organ sites

C82.00

Follicular lymphoma grade I, unspecified site

 

C82.01

Follicular lymphoma grade I, lymph nodes of head, face and neck

 

C82.02

Follicular lymphoma, grade I, intrathoracic lymph nodes

 

C82.03

Follicular lymphoma grade I, intra-abdominal lymph nodes

 

C82.04

Follicular lymphoma grade I, lymph nodes of axilla and upper limb

 

C82.05

Follicular lymphoma grade I, lymph nodes of inguinal regional and lower limb

 

C82.06

Follicular lymphoma grade I, intrapelvic lymph nodes

 

C82.07

Follicular lymphoma grade I, spleen

 

C82.08

Follicular lymphoma grade I, lymph nodes of multiple sites

 

C82.09

Follicular lymphoma grade I, extranodal and solid organ sites

 

C82.10

Follicular lymphoma grade II, unspecified site

 

C82.11

Follicular lymphoma grade II, lymph nodes of head, face and neck

 

C82.12

Follicular lymphoma, grade II, intrathoracic lymph nodes

 

C82.13

Follicular lymphoma grade II, intra-abdominal lymph nodes

 

C82.14

Follicular lymphoma grade II, lymph nodes of axilla and upper limb

 

C82.15

Follicular lymphoma grade II, lymph nodes of inguinal region and lower limb

 

C82.16

Follicular lymphoma grade II, intrapelvic lymph nodes

 

C82.17

Follicular lymphoma grade II, spleen

 

C82.18

Follicular lymphoma grade II, lymph nodes of multiple sites

 

C82.19

Follicular lymphoma grade II, extranodal and solid organ sites

 

C82.20

Follicular lymphoma grade III, unspecified, unspecified site

 

C82.21

Follicular lymphoma grade III, unspecified, lymph nodes of head, face and neck

 

C82.22

Follicular lymphoma, grade III, unspecified, intrathoracic lymph nodes

 

C82.23

Follicular lymphoma grade III, unspecified, intra-abdominal lymph nodes

 

C82.24

Follicular lymphoma grade III, unspecified, lymph nodes of axilla and upper limb

 

C82.25

Follicular lymphoma grade III, unspecified, lymph nodes of inguinal region and lower limb

 

C82.26

Follicular lymphoma grade III, unspecified, intrapelvic lymph nodes

 

C82.27

Follicular lymphoma grade III, unspecified, spleen

 

C82.28

Follicular lymphoma grade III, unspecified, lymph nodes of multiple sites

 

C82.29

Follicular lymphoma grade III, unspecified, extranodal and solid organ sites

 

C82.30

Follicular lymphoma grade IIIa, unspecified site

 

C82.31

Follicular lymphoma grade IIIa, lymph nodes of head, face and neck

 

C82.32

Follicular lymphoma, grade IIIa, intrathoracic lymph nodes

 

C82.33

Follicular lymphoma grade IIIa, intra-abdominal lymph nodes

 

C82.34

Follicular lymphoma grade IIIa, lymph nodes of axilla and upper limb

 

C82.35

Follicular lymphoma grade IIIa, lymph nodes of inguinal region and lower limb

 

C82.36

Follicular lymphoma grade IIIa, intrapelvic lymph nodes

 

C82.37

Follicular lymphoma grade IIIa, spleen

 

C82.38

Follicular lymphoma grade IIIa, lymph nodes of multiple sites

 

C82.39

Follicular lymphoma grade IIIa, extranodal and solid organ sites

 

C82.40

Follicular lymphoma grade IIIb, unspecified site

 

C82.41

Follicular lymphoma grade IIIb, lymph nodes of head, face and neck

 

C82.42

Follicular lymphoma, grade IIIb, intrathoracic lymph nodes

 

C82.43

Follicular lymphoma grade IIIb, intra-abdominal lymph nodes

 

C82.44

Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb

 

C82.45

Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb

 

C82.46

Follicular lymphoma grade IIIb, intrapelvic lymph nodes

 

C82.47

Follicular lymphoma grade IIIb, spleen

 

C82.48

Follicular lymphoma grade IIIb, lymph nodes of multiple sites

 

C82.49

Follicular lymphoma grade IIIb, extranodal and solid organ sites

 

C82.50

Diffuse follicle center lymphoma, unspecified site

 

C82.51

Diffuse follicle center lymphoma, lymph nodes of head, face and neck

 

C82.52

Diffuse follicle center lymphoma, intrathoracic lymph nodes

 

C82.53

Diffuse follicle center lymphoma, intra-abdominal lymph nodes

 

C82.54

Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb

 

C82.55

Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb

 

C82.56

Diffuse follicle center lymphoma, intrapelvic lymph nodes

 

C82.57

Diffuse follicle center lymphoma, spleen

 

C82.58

Diffuse follicle center lymphoma, lymph nodes of multiple sites

 

C82.59

Diffuse follicle center lymphoma, extranodal and solid organ sites

 

C82.60

Cutaneous follicle center lymphoma, unspecified site

 

C82.61

Cutaneous follicle center lymphoma, lymph nodes of head, face and neck

 

C82.62

Cutaneous follicle center lymphoma, intrathoracic lymph nodes

 

C82.63

Cutaneous follicle center lymphoma, intra-abdominal lymph nodes

 

C82.64

Cutaneous follicle center lymphoma, lymph nodes of axilla and upper limb

 

C82.65

Cutaneous follicle center lymphoma, lymph nodes of inguinal region and lower limb

 

C82.66

Cutaneous follicle center lymphoma, intrapelvic lymph nodes

 

C82.67

Cutaneous follicle center lymphoma, spleen

 

C82.68

Cutaneous follicle center lymphoma, lymph nodes of multiple sites

 

C82.69

Cutaneous follicle center lymphoma, extranodal and solid organ sites

 

C82.80

Other types of follicular lymphoma, unspecified site

 

C82.81

Other types of follicular lymphoma, lymph nodes of head, face and neck

 

C82.82

Other types of follicular lymphoma, intrathoracic lymph nodes

 

C82.83

Other types of follicular lymphoma, intra-abdominal lymph nodes

 

C82.84

Other types of follicular lymphoma, lymph nodes of axilla and upper limb

 

C82.85

Other types of follicular lymphoma, lymph nodes of inguinal region and lower limb

 

C82.86

Other types of follicular lymphoma, intrapelvic lymph nodes

 

C82.87

Other types of follicular lymphoma, spleen

 

C82.88

Other types of follicular lymphoma, lymph nodes of multiple sites

 

C82.89

Other types of follicular lymphoma, extranodal and solid organ sites

 

C82.90

Follicular lymphoma, unspecified, unspecified site

 

C82.91

Follicular lymphoma, unspecified, lymph nodes of head, face and neck

 

C82.92

Follicular lymphoma, unspecified, intrathoracic lymph nodes

 

C82.93

Follicular lymphoma, unspecified, intra-abdominal lymph nodes

 

C82.94

Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb

 

C82.95

Follicular lymphoma, unspecified lymph nodes of inguinal region and lower limb

 

C82.96

Follicular lymphoma, unspecified, intrapelvic lymph nodes

 

C82.97

Follicular lymphoma, unspecified, spleen

 

C82.98

Follicular lymphoma, unspecified, lymph nodes of multiple sites

 

C82.99

Follicular lymphoma, unspecified, extranodal and solid organ sites

 

C83.00

Small cell B-cell lymphoma, unspecified site

 

C83.01

Small cell B-cell lymphoma, lymph nodes of head, face and neck

 

C83.02

Small cell B-cell lymphoma, intrathoracic lymph nodes

 

C83.03

Small cell B-cell lymphoma, intra-abdominal lymph nodes

 

C83.04

Small cell B-cell lymphoma, lymph nodes of axilla and upper limb

 

C83.05

Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb

 

C83.06

Small cell B-cell lymphoma, intrapelvic lymph nodes

 

C83.07

Small cell B-cell lymphoma, spleen

 

C83.08

Small cell B-cell lymphoma, lymph nodes of multiple sites

 

C83.09

Small cell B-cell lymphoma, extranodal and solid organ sites

 

C83.10

Mantle cell lymphoma, unspecified site

 

C83.11

Mantle cell lymphoma, lymph nodes of head, face and neck

 

C83.12

Mantle cell lymphoma, intrathoracic lymph nodes

 

C83.13

Mantle cell lymphoma, intra-abdominal lymph nodes

 

C83.14

Mantle cell lymphoma, lymph nodes of axilla and upper limb

 

C83.15

Mantle cell lymphoma, lymph nodes of inguinal region and lower limb

 

C83.16

Mantle cell lymphoma, intrapelvic lymph nodes

 

C83.17

Mantle cell lymphoma, spleen

 

C83.18

Mantle cell lymphoma, lymph nodes of multiple sites

 

C83.19

Mantle cell lymphoma, extranodal and solid organ sites

 

C83.30

Diffuse large B-cell lymphoma unspecified site

 

C83.31

Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck

 

C83.32

Diffuse large B-cell lymphoma intrathoracic lymph nodes

 

C83.33

Diffuse large B-cell lymphoma intra-abdominal lymph nodes

 

C83.34

Diffuse large B-cell lymphoma lymph nodes of axilla and upper limb

 

C83.35

Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb

 

C83.36

Diffuse large B-cell lymphoma intrapelvic lymph nodes

 

C83.37

Diffuse large B-cell lymphoma, spleen

 

C83.38

Diffuse large B-cell lymphoma lymph nodes of multiple sites

 

C83.39

Diffuse large B-cell lymphoma extranodal and solid organ sites

 

C83.80

Other non-follicular lymphoma, unspecified site

 

C83.81

Other non-follicular lymphoma, lymph nodes of head, face and neck

 

C83.82

Other non-follicular lymphoma, intrathoracic lymph nodes

 

C83.83

Other non-follicular lymphoma, intra-abdominal lymph nodes

 

C83.84

Other non-follicular lymphoma, lymph nodes of axilla and upper limb

 

C83.85

Other non-follicular lymphoma, lymph nodes of inguinal region and lower limb

 

C83.86

Other non-follicular lymphoma, intrapelvic lymph nodes

 

C83.87

Other non-follicular lymphoma, spleen

 

C83.88

Other non-follicular lymphoma, lymph nodes of multiple sites

 

C83.89

Other non-follicular lymphoma, extranodal and solid organ sites

 

C83.90

Non-follicular (diffuse) lymphoma, unspecified site

 

C83.91

Non-follicular (diffuse) lymphoma, unspecified lymph nodes of head, face, and neck

 

C83.92

Non-follicular (diffuse) lymphoma, unspecified intrathoracic lymph nodes

 

C83.93

Non-follicular (diffuse) lymphoma, unspecified intra-abdominal lymph nodes

 

C83.94

Non-follicular (diffuse) lymphoma, unspecified lymph nodes of axilla and upper limb

 

C83.95

Non-follicular (diffuse) lymphoma, unspecified lymph nodes of inguinal region and lower limb

 

C83.96

Non-follicular (diffuse) lymphoma, unspecified intrapelvic lymph nodes

 

C83.97

Non-follicular (diffuse) lymphoma, unspecified spleen

 

C83.98

Non-follicular (diffuse) lymphoma, unspecified lymph nodes of multiple sites

 

C83.99

Non-follicular (diffuse) lymphoma, unspecified extranodal and solid organ sites

 

C85.10

Unspecified B-cell lymphoma, unspecified site

C85.11

Unspecified B-cell lymphoma, lymph nodes of head, face, and neck

C85.12

Unspecified B-cell lymphoma, intrathoracic lymph nodes

C85.13

Unspecified B-cell lymphoma, intra-abdominal lymph nodes

C85.14

Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb

C85.15

Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb

C85.16

Unspecified B-cell lymphoma, intrapelvic lymph nodes

C85.17

Unspecified B-cell lymphoma, spleen

C85.18

Unspecified B-cell lymphoma, lymph nodes of multiple sites

C85.19

Unspecified B-cell lymphoma, extranodal and solid organ sites

C85.20

Mediastinal (thymic) large B-cell lymphoma, unspecified site

 

C85.21

Mediastinal (thymic) large B-cell lymphoma, lymph nodes of head, face and neck

 

C85.22

Mediastinal (thymic) large B-cell lymphoma, intrathoracic lymph nodes

 

C85.23

Mediastinal (thymic) large B-cell lymphoma, intra-abdominal lymph nodes

 

C85.24

Mediastinal (thymic) large B-cell lymphoma, lymph nodes of axilla and upper limb

 

C85.25

Mediastinal (thymic) large B-cell lymphoma, lymph nodes of inguinal region and lower limb

 

C85.26

Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes

 

C85.27

Mediastinal (thymic) large B-cell lymphoma, spleen

 

C85.28

Mediastinal (thymic) large B-cell lymphoma, lymph nodes of multiple sites

 

C85.29

Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites

 

C85.87

Other specified types of non-Hodgkin lymphoma, spleen

 

C88.0

Waldenström macroglobulinemia

 

C88.4

Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT-lymphoma)

 

C91.10

Chronic lymphocytic leukemia of B-cell type not having achieved remission

 

C91.12

Chronic lymphocytic leukemia of B-cell type in relapse

 

C91.40

Hairy cell leukemia not having achieved remission

 

C91.42

Hairy cell leukemia, in relapse

 

D47.Z1

Post-transplant lymphoproliferative disorder (PTLD)

 

D47.Z2

Other neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue – Castleman Disease

 

Z85.71

Personal history of Hodgkin lymphoma

Z85.72

Personal history of non-Hodgkin lymphomas

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes

Jurisdiction

NCD/LCA/LCD Document (s)

Contractor

J, M

A56380

Palmetto GBA

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

RITUXAN HYCELA® (rituximab & hyaluronidase human)

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