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Yescarta™ (axicabtagene ciloleucel) (Intravenous)

Policy Number: VP-0333

​  

Intravenous

 

Last Review Date: 10/30/2023

Date of Origin: 10/31/2017

Dates Reviewed: 10/2017, 11/2018, 10/2019, 12/2019, 11/2020, 04/2021, 11/2021, 05/2022, 11/2022, 11/2023

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

Coverage will be provided for one treatment course (1 dose of Yescarta) and may not be renewed.

  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

  • 1 infusion bag of up to 200 million autologous anti-CD19 CAR-positive viable T-cells

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

  • 1 billable unit (1 infusion of up to 200 million autologous anti-CD19 CAR-positive viable T-cells)
  1. Initial Approval Criteria 1

Submission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at the time of submission. Please provide documentation related to diagnosis, step therapy, and clinical markers (i.e. genetic and mutational testing) supporting initiation when applicable.  Please provide documentation via direct upload through the PA web portal or by fax.

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age (unless otherwise specified); AND
  • Patient does not have a clinically significant active systemic infection or inflammatory disorder; AND
  • Patient has not received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy, and will not receive live vaccines during axicabtagene ciloleucel treatment and until immune recovery following treatment; AND
  • Patient has been screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to collection of cells (leukapheresis); AND
  • Prophylaxis for infection will be followed according to local guidelines; AND
  • Healthcare facility has enrolled in the YESCARTA & TECARTUS REMS Program and training has been given to providers on the management of cytokine release syndrome (CRS) and neurological toxicities; AND
  • Patient has not received prior CAR-T therapy; AND
  • Patient has not received other anti-CD19 therapy (e.g., blinatumomab, tafasitamab, loncastuximab tesirine, etc.) OR patient previously received other anti-CD19 therapy and re-biopsy indicates CD-19 positive disease; AND
  • Used as a single agent (not applicable to lymphodepleting or additional chemotherapy while awaiting manufacture); AND
  • Patient has an ECOG performance status of 0-1; AND
  • Patient does not have primary central nervous system lymphoma; AND

B-Cell Lymphomas † ‡ Ф 1,7,12,13

  • Patient has histologic transformation of follicular lymphoma to diffuse large b-cell lymphoma (DLBCL); AND
    • Disease is refractory to first-line chemoimmunotherapy; OR
    • Used for treatment of disease that has relapsed within 12 months of first-line chemoimmunotherapy; OR
    • Patient has received two (2) or more prior lines of chemoimmunotherapy for indolent or transformed disease which must have included an anthracycline or anthracenedione-based regimen, unless contraindicated; OR
  • Patient has histologic transformation of nodal marginal zone lymphoma to DLBCL OR Richter’s transformation of CLL to DLBCL; AND
    • Patient has received two (2) or more prior lines of chemoimmunotherapy for indolent or transformed disease which must have included an anthracycline or anthracenedione-based regimen, unless contraindicated; OR
  • Patient has HIV-related large B-cell lymphoma (i.e., HIV-related DLBCL, primary effusion lymphoma, or HHV8-positive DLBCL, not otherwise specified), DLBCL, primary mediastinal large B-cell lymphoma (PMBCL), high grade B-cell lymphoma, or monomorphic post-transplant lymphoproliferative disorder (B-cell type); AND
    • Used as additional therapy for relapsed or refractory disease >12 months after completion of first-line therapy and partial response following second-line therapy OR
    • Used as additional therapy for patients with primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy; OR
    • Used for treatment of disease that is in second or greater relapse in patients with partial response, no response, or progressive disease following therapy for relapsed or refractory disease; OR
  • Patient has nodal marginal zone lymphoma (MZL) or follicular lymphoma (grade 1-2); AND
    • Used as third-line and subsequent therapy for partial response, no response, relapsed, or progressive disease; OR
  • Patient has extranodal marginal zone lymphoma (EMZL) of the stomach or of nongastric sites (noncutaneous); AND
    • Used as third-line and subsequent therapy for relapsed, refractory, or progressive disease; OR
  • Patient has splenic marginal zone lymphoma (MZL); AND
    • Used as third-line and subsequent therapy for disease recurrence

Pediatric Aggressive Mature B-Cell Lymphomas ‡ 2,7,11,15

  • Patient is ≤ 18 years of age; AND
  • Patient has primary mediastinal large B-Cell lymphoma; AND
  • Used as consolidation or additional therapy in patients with a partial response after therapy for relapsed or refractory disease; AND
  • Patient previously received ≥ 2 prior chemoimmunotherapy regimens

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

  1. Renewal Criteria 1

Coverage cannot be renewed.

  1. Dosage/Administration 1

Indication

Dose

B-Cell Lymphomas

Lymphodepleting chemotherapy:

  • Administer cyclophosphamide 500 mg/m2 and fludarabine 30 mg/m2 intravenously on the fifth, fourth, and third day before infusion of Yescarta.

Yescarta infusion:

  • Each single infusion bag of Yescarta contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. The target dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells (for patients 100 kg and above).

For autologous use only. For intravenous use only.

  • Yescarta is prepared from the patient’s peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure.
  • One treatment course consists of lymphodepleting chemotherapy followed by a single infusion of Yescarta.
  • Confirm Yescarta availability prior to starting the lymphodepleting regimen.
  • Confirm the patient’s identity matches the patient identifiers on the Yescarta cassette.

Premedication:

  • Premedicate with 650 mg acetaminophen and 12.5 mg diphenhydramine 1 hour prior to infusion. Only consider the use of prophylactic systemic corticosteroids in patients after weighing the potential benefits and risks.

Monitoring after infusion:

  • Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS and neurologic toxicities.
  • Instruct patients to remain within proximity of the certified healthcare facility for at least 4 weeks following infusion.
  • Instruct patients to refrain from driving or hazardous activities for at least 8 weeks following infusion.
  • Store infusion bag in the vapor phase of liquid nitrogen (less than or equal to minus 150°C). Thaw prior to infusion.
  • In case of manufacturing failure, a second manufacturing may be attempted.
  • Additional chemotherapy (not the lymphodepletion) may be necessary while the patient awaits the product.
  • Ensure that 2 doses of tocilizumab and emergency equipment are available prior to infusion and during the recovery period.
  • Yescarta contains human blood cells that are genetically modified with replication incompetent retroviral vector. Follow universal precautions and local biosafety guidelines for handling and disposal.
  1. Billing Code/Availability Information

HCPCS Code:

  • Q2041 - Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

NDC:

  • Yescarta suspension for intravenous infusion; 1 infusion bag (68 mL): 71287-0119-xx
  1. References
  1. Yescarta [package insert]. Santa Monica, CA; Kite Pharma, Inc.; November 2022. Accessed October 2023.
  2. Locke FL, Neelapu SS, Bartlett NL, et al. Phase 1 Results of ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295.
  3. Mejstrikova E, Hrusak O, Borowitz MJ, et al. CD19-negative relapse of pediatric B-cell precursor acute lymphoblastic leukemia following blinatumomab treatment. Blood Cancer J. 20177; 659. DOI 10.1038/s41408-017-0023-x
  4. Ruella M, Maus MV. Catch me if you can: Leukemia Escape after CD19-Directed T Cell Immunotherapies. Computational and Structural Biotechnology Journal 14 (2016) 357–362.
  5. Braig F, Brandt A, Goebeler M, et al. Resistance to anti-CD19/CD3 BiTE in acute lymphoblastic leukemia may be mediated by disrupted CD19 membrane trafficking. Blood; 129:1, 2017 Jan.
  6. Majzner RG, Mackall CL. Tumor Antigen Escape from CAR T-cell Therapy. Cancer Discov 2018;8:1219-1226.
  7. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) axicabtagene ciloleucel. National Comprehensive Cancer Network, 2023. 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 October 2023.
  8. Locke FL, Ghobadi A, Jacobson CA, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019;20(1):31-42. doi:10.1016/S1470-2045(18)30864-7.
  9. Neelapu SS, Jacobson CA, Oluwole OO, et al. Outcomes of older patients in ZUMA-1, a pivotal study of axicabtagene ciloleucel in refractory large B-cell lymphoma. Blood. 2020;135(23):2106-2109. doi:10.1182/blood.2019004162.
  10. Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377(26):2531-2544. doi: 10.1056/NEJMoa1707447.
  11. Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL). Journal of Clinical Oncology 2020 38:15_suppl, 8008-8008.
  12. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Version 3.2023. National Comprehensive Cancer Network, 2023. 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 October 2023.
  13. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas Version 5.2023. National Comprehensive Cancer Network, 2023. 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 October 2023.
  14. Locke FL, Miklos DB, Jacobson CA, et al; All ZUMA-7 Investigators and Contributing Kite Members. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):640-654. doi: 10.1056/NEJMoa2116133.
  15. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Aggressive Mature B-Cell Lymphomas Version 1.2023 National Comprehensive Cancer Network, 2023. 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 October 2023.

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 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

C83.30

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

C85.80

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 of 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

D47.Z1

Post-transplant lymphoproliferative disorder (PTLD)

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

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

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