vp-0184
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Gazyva (obinutuzumab) (Intravenous)

Policy Number: VP-0184

Last Review Date: 09/01/2020

Date of Origin:  01/02/2014

Dates Reviewed:  08/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 03/2016, 05/2016, 08/2016, 11/2016, 02/2017,0 5/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020

I. Length of Authorization

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

  • Coverage is provided for six 28-day cycles (6 months) and may NOT be renewed.

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

  • Coverage is provided for eight 21-day cycles (6 months) and may NOT be renewed.

All other indications:

  • Coverage is provided for six months and may be renewed for up to a maximum of two years of maintenance therapy.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Gazyva 1000 mg/40 mL vial: 2 vials every 21 days (6 vials for the initial 21-day cycle only)
  1. Max Units (per dose and over time) [HCPCS Unit]:

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

  • 10 billable units day 1, 90 billable units day 2, 100 billable units day 3, 200 billable units days 8 and 15 of Cycle 1 (21 days)

Maintenance Dose:

  • 200 billable units every 21 days

All other indications:

Loading Dose:

  • 100 billable units days 1, 8, 15 of Cycle 1 (28 days)

Maintenance Dose:

  • 100 billable units every 21 days for 8 cycles; then every 2 months for 2 years

III. Initial Approval Criteria 

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 

  • Patient does not have an active infection; 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
  • Patient has been screened for the presence of hepatitis B (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

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

  • Used as first-line therapy; AND
    • Used in combination with chlorambucil ; OR
    • Used in combination with acalabrutinib ; OR
    • Used in combination with venetoclax ; OR
    • Used as single agent therapy for disease with del(17p)/TP53 mutation; OR
    • Used in combination with bendamustine for disease without del(17p)/TP53 mutation (excluding use in frail patients with significant comorbidity [i.e., not able to tolerate purine analogs]); OR
  • Used for relapsed or refractory disease ; AND
    • Used as single agent therapy for disease without del(17p)/TP53 mutation

B-Cell Lymphomas 

  • Follicular Lymphoma (Grade 1-2)Ф
    • Used as first-line therapy for stage II non-contiguous, III, or IV disease; AND
      • Used in combination with chemotherapy [e.g., bendamustine or CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or CVP (cyclophosphamide, vincristine, prednisone)]; OR
    • Used as subsequent therapy, if not previously used as first-line therapy, for refractory or progressive disease; AND
      • Used in combination with chemotherapy [e.g., bendamustine or CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or CVP (cyclophosphamide, vincristine, prednisone)]; OR
      • Used as a single agent; OR
      • Used in combination with lenalidomide; OR
    • Used as a single agent for maintenance therapy; AND
      • Used as first-line consolidation therapy or extended dosing following chemoimmunotherapy; OR
      • Used as second-line consolidation therapy or extended dosing in patients who are refractory to rituximab; OR
      • Used in patients with histologic transformation to diffuse-large B-cell lymphoma with extensive co-existing follicular lymphoma who achieve a complete response to chemoimmunotherapy; OR
    • Used as a substitute for rituximab in patients experiencing rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis
  • MALT Lymphoma (Gastric or Non-Gastric) or Marginal Zone Lymphoma (Splenic or Nodal)
    • Used in combination with bendamustine; AND
      • Used as subsequent therapy, if not previously treated with bendamustine, for recurrent disease after prior treatment with rituximab (Splenic Marginal Zone Lymphoma only); OR
      • Used as subsequent therapy, if not previously treated with bendamustine, for recurrent or progressive disease (Gastric MALT Lymphoma only); OR
      • Used as subsequent therapy, if not previously treated with bendamustine, for refractory or progressive disease (Non-Gastric MALT or Nodal Marginal Zone Lymphoma only); OR
    • Used as a single agent for maintenance therapy as second-line consolidation or extended dosing in rituximab refractory patients treated with obinutuzumab and bendamustine for recurrent disease; OR
    • Used as a substitute for rituximab in patients experiencing rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis
  • Histologic Transformation of Nodal Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, High Grade B-Cell Lymphomas, Burkitt Lymphoma, AIDS Related B Cell Lymphomas, Post-Transplant Lymphoproliferative Disorders, or Castleman’s Disease
    • Used as a substitute for rituximab in patients experiencing rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis

FDA-labeled indication(s); Compendia recommended indication(s); Ф Orphan Drug

IV. Renewal Criteria 

Coverage may be renewed based on the following criteria:

  • Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe neutropenia/febrile neutropenia, severe thrombocytopenia, severe infusion-related reactions, hypersensitivity reactions including serum sickness, tumor lysis syndrome (TLS), serious bacterial, fungal, or viral infections, etc.; AND
  • Patient has been evaluated for the presence of progressive multifocal leukoencephalopathy (PML) and has been found to be negative; AND

CLL/SLL

  • Authorizations may NOT be renewed

Maintenance treatment of B-Cell Lymphomas

  • Length of therapy does not exceed 2 years

V. Dosage/Administration 

Indication

Dose

CLL/SLL

Combination therapy:

  • 100 mg day 1, 900 mg day 2, then 1000 mg days 8 and 15 of cycle 1 (loading doses)
  • 1000 mg on Day 1 of cycles 2-6 (28-day cycle)

Monotherapy:

  • 100 mg day 1, 900 mg day 2, then 1000 mg days 8 and 15 of cycle 1 (loading doses)
  • 1000 mg on Day 1 of cycles 2-8 (21-day cycle)

-OR-

  • 100mg day 1, 900 mg day 2, 1000 mg day 3, 2000 mg day 8 and 15 of cycle 1 (loading doses)
  • 2000 mg on Day 1 of cycles 2-8 (21-day cycle)

B-Cell Lymphomas

Initial Combination therapy:

  • 1000 mg days 1, 8, & 15 of cycle 1 (loading doses); given in combination with chemotherapy or lenalidomide
  • Combination chemotherapy:
  • 1000 mg day 1 of cycles 2-6 (28-day cycle) in combination with bendamustine
  • 1000 mg day 1 of cycles 2-6 (21-day cycle) in combination with CHOP, followed by 2 additional 21-day cycles of Gazyva alone
  • 1000 mg day 1 of cycles 2-8 (21-day cycle) with CVP
  • In combination with lenalidomide:
  • 1000 mg day 1 of cycles 2-6 (28-day cycle)

Initial Monotherapy:

  • 1000 mg once a week for 4 weeks on days 1, 8, 15, & 22

Maintenance therapy for use after initial combination therapy or monotherapy:

  • 1000 mg every 2 months for up to two years as monotherapy
  • NOTE: When initial therapy is given in combination with lenalidomide, the first year of maintenance therapy will be given with lenalidomide, followed by an additional year of monotherapy

VI. Billing Code/Availability Information

HCPCS Code:

  • J9301 – Injection, obinutuzumab, 10 mg; 1 billable unit = 10 mg

NDC:

  • Gazyva 1000 mg/40 mL single-dose vial: 50242-0070-xx

VII. References

  1. Gazyva [package insert]. South San Francisco, CA; Genentech, Inc; March 2020. Accessed July 2020.
  2. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) obinutuzumab. National Comprehensive Cancer Network, 2020. 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 July 2020.
  3. Goede V, Fischer K, Busch R, et al. Chemoimmunotherapy with GA101 plus chlorambucil in patients with chronic lymphocytic leukemia and comorbidity: results of the CLL11 (BO21004) safety run-in. Leukemia. 2013 Apr; 27(5):1172-4. doi: 10.1038/leu.2012.252. Epub 2012 Aug 31.
  4. Sehn LH, Chua N, Mayer J, et al. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016 Jun 23. pii: S1470-2045(16)30097-3.
  5. Cheson BD, Chua N, Mayer J, et al. Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol. 2018 36:22, 2259-2266.
  6. Marcus R, Davies A, Ando K, et al. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med 2017; 377:1331.
  7. Morschhauser F, Le Gouill S, Feugier P, et al. Obinutuzumab combined with lenalidomide for relapsed or refractory follicular B-cell lymphoma (GALEN): a multicentre, single-arm, phase 2 study. Lancet Haematol. 2019;6(8):e429e437. doi:10.1016/S2352-3026(19)30089-4.
  8. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019;380(23):22252236. doi:10.1056/NEJMoa1815281.
  9. Sharman JP, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL) [abstract]. Blood 2019;134:Abstract 31.
  10. Sharman JP, Yimer HA, Boxer M, et al. Results of a phase II multicenter study of obinutuzumab plus bendamustine in pts with previously untreated chronic lymphocytic leukemia (CLL). J Clin Oncol. 2017;35(15_suppl):7523-7523.
  11. Byrd JC, Flynn JM, Kipps TJ, et al. Randomized phase 2 study of obinutuzumab monotherapy in symptomatic, previously untreated chronic lymphocytic leukemia. Blood. 2016;127(1):7986. doi:10.1182/blood-2015-03-634394.
  12. Cartron G, de Guibert S, Dilhuydy MS, et al. Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study. Blood. 2014: 2196-2202.
  13. Sehn LH, Goy A, Offner FC, et al. Randomized Phase II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the GAUSS Study. J Clin Oncol. 2015;33(30):34673474. doi:10.1200/JCO.2014.59.2139.
  14. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Version 4.2020. National Comprehensive Cancer Network, 2020. 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 July 2020.
  15. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas Version 2.2020. National Comprehensive Cancer Network, 2020. 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 July 2020.
  16. Palmetto GBA. Local Coverage Article (LCA): Billing and Coding for Chemotherapy (A56141). Centers for Medicare & Medicaid Services, Inc. Updated on 05/26/2020 with effective date 04/30/2020. Accessed July 2020.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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 region 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 site

C82.21

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

C82.22

Follicular lymphoma grade III intrathoracic lymph nodes

C82.23

Follicular lymphoma grade III intra-abdominal lymph nodes

C82.24

Follicular lymphoma grade III lymph nodes of axilla and upper limb

C82.25

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

C82.26

Follicular lymphoma grade III intrapelvic lymph nodes

C82.27

Follicular lymphoma grade III spleen

C82.28

Follicular lymphoma grade III lymph nodes of multiple sites

C82.29

Follicular lymphoma grade III 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 lymph nodes of multiple sites

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  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

C83.70

Burkitt lymphoma, unspecified site

C83.71

Burkitt lymphoma, lymph nodes of head, face, and neck

C83.72

Burkitt lymphoma, intrathoracic lymph nodes

C83.73

Burkitt lymphoma, intra-abdominal lymph nodes

C83.74

Burkitt lymphoma, lymph nodes of axilla and upper limb

C83.75

Burkitt lymphoma, lymph nodes of inguinal region and lower limb

C83.76

Burkitt lymphoma, intrapelvic lymph nodes

C83.77

Burkitt lymphoma, spleen

C83.78

Burkitt lymphoma, lymph nodes of multiple sites

C83.79

Burkitt 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, 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

C85.80

Other specified types of non-Hodgkin lymphoma, unspecified site

C85.81

Other specified types of non-Hodgkin lymphoma, lymph nodes of head, face, and neck

C85.82

Other specified types of non-Hodgkin lymphoma, intrathoracic lymph nodes

C85.83

Other specified types of non-Hodgkin lymphoma, intra-abdominal lymph nodes

C85.84

Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb

C85.85

Other specified types of non-Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C85.86

Other specified types of non-Hodgkin lymphoma, intrapelvic lymph nodes

C85.87

Other specified types of non-Hodgkin lymphoma, spleen

C85.88

Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites

C85.89

Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites

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

D36.0

Benign neoplasm of lymph nodes

D47.Z1

Post-transplant lymphoproliferative disorder (PTLD)

D47.Z2

Castleman disease

R59.0

Localized enlarged lymph nodes

R59.1

Generalized enlarged lymph nodes

R59.9

Enlarged lymph nodes, unspecified

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

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Jurisdiction(s): J&M

NCD/LCD/LCA Document (s): A56141

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?Date=04/19/2020&DocID=A56141&bc=ggAAAAAAAAAA&

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