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Levoleucovorin: Fusilev®; Khapzory™Ψ

Policy Number: PH-0183

Intravenous

Last Review Date: 03/05/2024

Date of Origin:  01/02/2014

Dates Reviewed:  08/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 09/2019, 04/2020, 03/2021, 03/2022, 03/2023, 03/2024

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

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 1-3

Coverage will be provided for 90 days and may be renewed.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:

   Fusilev

  • Fusilev 50 mg single-dose vial: 25 vials per 28 days
  • Fusilev 175 mg/17.5 mL single-dose vial: 8 vials per 28 days
  • Fusilev 250 mg/25 mL single-dose vial: 5 vials per 28 days

Khapzory

  • Khapzory 175 mg single-dose vial: 8 vials per 28 days
  • Khapzory 300 mg single-dose vial: 4 vials per 28 days
  1. Max Units (per dose and over time) [HCPCS Unit]:

In combination with methotrexate or for inadvertent overdosage with folic acid antagonists

  • 1,200 billable units every 28 days

In combination with fluorouracil

  • 2,500 billable units every 28 days
  1. Initial Approval Criteria 1-3

Coverage is provided in the following conditions:

  • Patient is at least 6 years of age; AND

Universal Criteria 1-3

  • Patient does not have pernicious anemia or vitamin B12 deficiency megaloblastic anemia; AND
  • Racemic d,l-leucovorin calcium is not obtainable (in any dosage strength) as confirmed by FDA Drug shortage website located at: http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm; AND
  • Khapzory ONLY: Patient had an inadequate response, or has a contraindication or intolerance, to Fusilev (levoleucovorin); AND

Bone Cancer (Osteosarcoma) † ‡ Φ, Dedifferentiated Chondrosarcoma ‡, High-Grade Undifferentiated Pleomorphic Sarcoma (UPS) ‡ 1-4

  • Patient is undergoing high-dose methotrexate chemotherapy treatment; OR
  • Used as rescue therapy in combination with a chemotherapy regimen containing high-dose methotrexate

Reduction of toxicity due to impaired elimination or inadvertent overdose with folic acid antagonists † 1-2

  • Patient is undergoing treatment with a folic acid antagonist, such as methotrexate; AND
  • Patient has developed toxicity due to impaired elimination or inadvertent overdosage of the folic acid antagonist (i.e., methotrexate)

Colorectal Cancer † ‡ Φ 1-3

  • Must be used in combination with fluorouracil-based regimens

Gestational Trophoblastic Neoplasia ‡ 3

  • Used in combination with a methotrexate-based regimen

Used in combination with high-dose methotrexate for the following ‡: 1-3

  • Acute Lymphoblastic Leukemia/Pediatric Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
  • Patient has one of the following Central Nervous System (CNS) Cancers:
    • Primary CNS Lymphoma
    • Brain Metastases
    • Leptomeningeal Metastases
  • Patient has one of the following B-Cell Lymphomas:
    • Burkitt Lymphoma
    • Diffuse Large B-Cell Lymphoma (DLBCL)
    • High-Grade B-Cell Lymphoma
    • HIV-Related B-Cell Lymphoma
    • Mantle Cell Lymphoma
    • Post-Transplant Lymphoproliferative Disorders (PTLD)
  • Patient has one of the following T-Cell Lymphomas:
    • Peripheral T-Cell Lymphomas
    • Adult T-Cell Leukemia/Lymphoma
    • Hepatosplenic T-Cell Lymphoma
    • Extranodal NK/T-Cell Lymphoma
  • Patient has one of the following Pediatric Aggressive Mature B-Cell Lymphomas:
    • Burkitt Lymphoma
    • DLBCL
    • Primary Mediastinal Large B-Cell Lymphoma
  • Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma (Used for the management of symptomatic Bing-Neel syndrome)

Used in combination with fluorouracil-based regimens for the following ‡: 1-3

  • Ampullary Adenocarcinoma
  • Anal Carcinoma
  • Appendiceal Adenocarcinoma
  • Biliary Tract Cancers (Gallbladder Cancer or and Intra-/Extrahepatic Cholangiocarcinoma)
  • Cervical Cancer
  • Bladder Cancer (Non-Urothelial and Urothelial with Variant Histology)
  • Esophageal and Esophagogastric Junction Cancers
  • Gastric Cancer
  • Patient has one of the following Neuroendocrine and Adrenal Tumors:
    • Extrapulmonary Poorly Differentiated Neuroendocrine Carcinoma
    • Large or Small Cell Carcinoma
    • Mixed Neuroendocrine-Non-Neuroendocrine Neoplasms
    • Neuroendocrine Tumors of the Pancreas (Well-Differentiated Grade 1/2)
    • Well-Differentiated Grade 3 Neuroendocrine Tumors
  • Occult Primary
  • Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Mucinous Neoplasms of the Ovary)
  • Pancreatic Adenocarcinoma
  • Small Bowel Adenocarcinoma
  • Thymoma and Thymic Carcinoma

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Φ Orphan Drug

  1. Renewal Criteria 1-3

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: hypersensitivity reactions, hypercalcemia and severe gastrointestinal disorders (i.e., stomatitis and severe diarrhea); AND
  • Patient is responding to therapy
  1. Dosage/Administration 1-2

Indication

Dose

In combination with methotrexate (MTX)
  • Administer 7.5 mg (approximately 5 mg/m2) IV every 6 hours for 10 doses starting 24 hours after beginning of methotrexate infusion.
    • Dosing is based on a methotrexate dose of 12 grams/m2 administered by intravenous infusion over 4 hours.
    • Continue treatment until methotrexate levels are less than 5 x 10‐8 M (0.05 micromolar)
    • Adjust dose if necessary based on methotrexate elimination (Note: refer to Full Prescribing Information for further information).

Reduction of toxicity due to impaired elimination of MTX or inadvertent overdose with folic acid antagonists
  • Administer 7.5 mg (approximately 5 mg/m2) IV every 6 hours until methotrexate levels are less than 5 x 10‐8 M (0.05 micromolar).
  • Monitor serum creatinine and methotrexate levels at least every 24 hours. Increase the dose of levoleucovorin to 50 mg/m2 intravenously every 3 hours until the methotrexate level is less than 5 x 10-8 M for the following:
  • if the serum creatinine at 24-hours increases 50% or more compared to baseline
  • if the methotrexate level at 24-hours is greater than 5 x 10-6 M
  • if the methotrexate level at 48-hours is greater than 9 x 10-7 M

In combination with fluorouracil (5-FU)
  • Administer 100 mg/m2 by intravenous injection over a minimum of 3 minutes, followed by 5-FU at 370 mg/m2 by intravenous injection.

OR

  • Administer 10 mg/m2 by intravenous injection, followed by 5-FU at 425 mg/m2 by intravenous injection.

  • Treatment is repeated daily for five days. This five-day treatment course may be repeated at 4-week (28-day) intervals, for 2 courses and then repeated at 4 to 5 week (28 to 35 day) intervals provided that the patient has completely recovered from the toxic effects of the prior treatment course.

Alternate Dosing Regimen

  • Administer 200 mg/m2 by intravenous injection DAY 1 followed by 5-FU 400 mg/m2 bolus on DAY 1, then 5-FU 1200 mg/m2/day x 2 days IV continuous infusion; repeat every 14 days.
  1. Billing Code/Availability Information

HCPCS Code(s):

  • J0641 – Injection, levoleucovorin, not otherwise specified, 0.5 mg; 1 billable unit = 0.5 mg (applicable to Fusilev; levoleucovorin calcium)
  • J0642 – Injection, levoleucovorin (khapzory), 0.5 mg; 1 billable unit = 0.5 mg

NDC(s):

  • Fusilev 50 mg single-dose vial powder for injection: 72893-0009-xx *
  • Fusilev 175 mg/17.5 mL single-dose vial solution for injection: 72893-0013-xx *§
  • Fusilev 250 mg/25 mL single-dose vial solution for injection: 72893-0014-xx *§
  • Khapzory 175 mg single-dose vial powder for injection: 72893-0004-xx Ψ
  • Khapzory 300 mg single-dose vial powder for injection: 72893-0006-xx Ψ

* Generics available through various manufacturers

§ Brand name no longer commercially available

Ψ Khapzory was approved by the FDA as a 505(b)(2) NDA of the innovator product, Fusilev (levoleucovorin). These products are not rated as therapeutically equivalent to their reference listed drug in the Food and Drug Administration’s (FDA) Orange Book, and are therefore considered single source products based on the statutory definition of “single source drug” in section 1847A(c)(6) of the Act. Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA
  1. References
  1. Fusilev [package insert]. East Windsor, NJ; Acrotech Biopharma LLC; November 2020. Accessed January 2024.
  2. Khapzory [package insert]. East Windsor, NJ; Acrotech Biopharma LLC; March 2020. Accessed January 2024.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) levoleucovorin. 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.
  4. Goorin A, Strother D, Poplack D, et al. Safety and efficacy of l-leucovorin rescue following high-dose methotrexate for osteosarcoma. Med Pediatr Oncol. 1995 Jun; 24(6):362-7.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C15.3

Malignant neoplasm of upper third of esophagus

C15.4

Malignant neoplasm of middle third of esophagus

C15.5

Malignant neoplasm of the lower third of esophagus

C15.8

Malignant neoplasm of overlapping sites of esophagus

C15.9

Malignant neoplasm of esophagus, unspecified

C16.0

Malignant neoplasm of cardia

C16.1

Malignant neoplasm of fundus of stomach

C16.2

Malignant neoplasm of body of stomach

C16.3

Malignant neoplasm of pyloric antrum

C16.4

Malignant neoplasm of pylorus

C16.5

Malignant neoplasm of lesser curvature of stomach, unspecified

C16.6

Malignant neoplasm of greater curvature of stomach, unspecified

C16.8

Malignant neoplasm of overlapping sites of stomach

C16.9

Malignant neoplasm of stomach, unspecified

C17.0

Malignant neoplasm of duodenum

C17.1

Malignant neoplasm of jejunum

C17.2

Malignant neoplasm of ileum

C17.3

Meckel's diverticulum, malignant

C17.8

Malignant neoplasm of overlapping sites of small intestine

C17.9

Malignant neoplasm of small intestine, unspecified

C18.0

Malignant neoplasm of cecum

C18.1

Malignant neoplasm of appendix

C18.2

Malignant neoplasm of ascending colon

C18.3

Malignant neoplasm of hepatic flexure

C18.4

Malignant neoplasm of transverse colon

C18.5

Malignant neoplasm of splenic flexure

C18.6

Malignant neoplasm of descending colon

C18.7

Malignant neoplasm of sigmoid colon

C18.8

Malignant neoplasm of overlapping sites of colon

C18.9

Malignant neoplasm of colon, unspecified

C19

Malignant neoplasm of rectosigmoid junction

C20

Malignant neoplasm of rectum

C21.0

Malignant neoplasm of anus, unspecified

C21.1

Malignant neoplasm of anal canal

C21.2

Malignant neoplasm of cloacogenic zone

C21.8

Malignant neoplasm of overlapping sites of rectum, anus and anal canal

C22.1

Intrahepatic bile duct carcinoma

C23

Malignant neoplasm of gallbladder

C24.0

Malignant neoplasm of extrahepatic bile duct

C24.1

Malignant neoplasm of ampulla of Vater

C24.8

Malignant neoplasm of overlapping sites of biliary tract

C24.9

Malignant neoplasm of biliary tract, unspecified

C25.0

Malignant neoplasm of head of pancreas

C25.1

Malignant neoplasm of body of pancreas

C25.2

Malignant neoplasm of tail of pancreas

C25.3

Malignant neoplasm of pancreatic duct

C25.7

Malignant neoplasm of other parts of pancreas

C25.8

Malignant neoplasm of overlapping sites of pancreas

C25.9

Malignant neoplasm of pancreas, unspecified

C37

Malignant neoplasm of thymus

C40.00

Malignant neoplasm of scapula and long bones of unspecified upper limb

C40.01

Malignant neoplasm of scapula and long bones of right upper limb

C40.02

Malignant neoplasm of scapula and long bones of left upper limb

C40.10

Malignant neoplasm of short bones of unspecified upper limb

C40.11

Malignant neoplasm of short bones of right upper limb

C40.12

Malignant neoplasm of short bones of left upper limb

C40.20

Malignant neoplasm of long bones of unspecified lower limb

C40.21

Malignant neoplasm of long bones of right lower limb

C40.22

Malignant neoplasm of long bones of left lower limb

C40.30

Malignant neoplasm of short bones of unspecified lower limb

C40.31

Malignant neoplasm of short bones of right lower limb

C40.32

Malignant neoplasm of short bones of left lower limb

C40.80

Malignant neoplasm of overlapping sites of bone and articular cartilage of unspecified limb

C40.81

Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb

C40.82

Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb

C40.90

Malignant neoplasm of unspecified bones and articular cartilage of unspecified limb

C40.91

Malignant neoplasm of unspecified bones and articular cartilage of right limb

C40.92

Malignant neoplasm of unspecified bones and articular cartilage of left limb

C41.0

Malignant neoplasm of bones of skull and face

C41.1

Malignant neoplasm of mandible

C41.2

Malignant neoplasm of vertebral column

C41.3

Malignant neoplasm of ribs, sternum and clavicle

C41.4

Malignant neoplasm of pelvic bones, sacrum and coccyx

C41.9

Malignant neoplasm of bone and articular cartilage, unspecified

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C53.0

Malignant neoplasm of endocervix

C53.1

Malignant neoplasm of exocervix

C53.8

Malignant neoplasm of overlapping sites of cervix uteri

C53.9

Malignant neoplasm of cervix uteri, unspecified

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.3

Malignant neoplasm of bilateral ovaries

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

C58

Malignant neoplasm of placenta

C67.0

Malignant neoplasm of trigone of bladder

C67.1

Malignant neoplasm of dome of bladder

C67.2

Malignant neoplasm of lateral wall of bladder

C67.3

Malignant neoplasm of anterior wall of bladder

C67.4

Malignant neoplasm of posterior wall of bladder

C67.5

Malignant neoplasm of bladder neck

C67.6

Malignant neoplasm of ureteric orifice

C67.7

Malignant neoplasm of urachus

C67.8

Malignant neoplasm of overlapping sites of bladder

C67.9

Malignant neoplasm of bladder, unspecified

C78.00

Secondary malignant neoplasm of unspecified lung

C78.01

Secondary malignant neoplasm of right lung

C78.02

Secondary malignant neoplasm of left lung

C78.6

Secondary malignant neoplasm of retroperitoneum and peritoneum

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

C79.31

Secondary malignant neoplasm of brain

C79.32

Secondary malignant neoplasm of cerebral meninges

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

C7A.098

Malignant carcinoid tumors of other sites

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C7A.8

Other malignant neuroendocrine tumors

C7B.00

Secondary carcinoid tumors unspecified site

C7B.01

Secondary carcinoid tumors of distant lymph nodes

C7B.02

Secondary carcinoid tumors of liver

C7B.03

Secondary carcinoid tumors of bone

C7B.04

Secondary carcinoid tumors of peritoneum

C7B.09

Secondary carcinoid tumors of other sites

C7B.8

Other secondary neuroendocrine tumors

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

C83.50

Lymphoblastic (diffuse) lymphoma unspecified site

C83.51

Lymphoblastic (diffuse) lymphoma lymph nodes of head, face, and neck

C83.52

Lymphoblastic (diffuse) lymphoma intrathoracic lymph nodes

C83.53

Lymphoblastic (diffuse) lymphoma intra-abdominal lymph nodes

C83.54

Lymphoblastic (diffuse) lymphoma lymph nodes of axilla and upper limb

C83.55

Lymphoblastic (diffuse) lymphoma lymph nodes of inguinal region and lower limb

C83.56

Lymphoblastic (diffuse) lymphoma intrapelvic lymph nodes

C83.57

Lymphoblastic (diffuse) lymphoma spleen

C83.58

Lymphoblastic (diffuse) lymphoma lymph nodes of multiple sites

C83.59

Lymphoblastic (diffuse) 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

C84.40

Peripheral T-cell lymphoma, not classified, unspecified site

C84.41

Peripheral T-cell lymphoma, not classified, lymph nodes of head, face, and neck

C84.42

Peripheral T-cell lymphoma, not classified, intrathoracic lymph nodes

C84.43

Peripheral T-cell lymphoma, not classified, intra-abdominal lymph nodes

C84.44

Peripheral T-cell lymphoma, not classified, lymph nodes of axilla and upper limb

C84.45

Peripheral T-cell lymphoma, not classified, lymph nodes of inguinal region and lower limb

C84.46

Peripheral T-cell lymphoma, not classified, intrapelvic lymph nodes

C84.47

 Peripheral T-cell lymphoma, not classified, spleen

C84.48

Peripheral T-cell lymphoma, not classified, lymph nodes of multiple sites

C84.49

Peripheral T-cell lymphoma, not classified, extranodal and solid organ sites

C84.60

Anaplastic large cell lymphoma, ALK-positive, unspecified site

C84.61

Anaplastic large cell lymphoma, ALK-positive, lymph nodes of head, face, and neck

C84.62

Anaplastic large cell lymphoma, ALK-positive, intrathoracic lymph nodes

C84.63

Anaplastic large cell lymphoma, ALK-positive, intra-abdominal lymph nodes

C84.64

Anaplastic large cell lymphoma, ALK-positive, lymph nodes of axilla and upper limb

C84.65

Anaplastic large cell lymphoma, ALK-positive, lymph nodes of inguinal region and lower limb

C84.66

Anaplastic large cell lymphoma, ALK-positive, intrapelvic lymph nodes

C84.67

Anaplastic large cell lymphoma, ALK-positive, spleen

C84.68

Anaplastic large cell lymphoma, ALK-positive, lymph nodes of multiple sites

C84.69

Anaplastic large cell lymphoma, ALK-positive, extranodal and solid organ sites

C84.70

Anaplastic large cell lymphoma, ALK-negative, unspecified site

C84.71

Anaplastic large cell lymphoma, ALK-negative, lymph nodes of head, face, and neck

C84.72

Anaplastic large cell lymphoma, ALK-negative, intrathoracic lymph nodes

C84.73

Anaplastic large cell lymphoma, ALK-negative, intra-abdominal lymph nodes

C84.74

Anaplastic large cell lymphoma, ALK-negative, lymph nodes of axilla and upper limb

C84.75

Anaplastic large cell lymphoma, ALK-negative, lymph nodes of inguinal region and lower limb

C84.76

Anaplastic large cell lymphoma, ALK-negative, intrapelvic lymph nodes

C84.77

Anaplastic large cell lymphoma, ALK-negative, spleen

C84.78

Anaplastic large cell lymphoma, ALK-negative, lymph nodes of multiple sites

C84.79

Anaplastic large cell lymphoma, ALK-negative, extranodal and solid organ sites

C84.90

Mature T/NK-cell lymphomas, unspecified site

C84.91

Mature T/NK-cell lymphomas, unspecified lymph nodes of head, face, and neck

C84.92

Mature T/NK-cell lymphomas, unspecified intrathoracic lymph nodes

C84.93

Mature T/NK-cell lymphomas, unspecified intra-abdominal lymph nodes

C84.94

Mature T/NK-cell lymphomas, unspecified lymph nodes of axilla and upper limb

C84.95

Mature T/NK-cell lymphomas, unspecified lymph nodes of inguinal region and lower limb

C84.96

Mature T/NK-cell lymphomas, unspecified intrapelvic lymph nodes

C84.97

Mature T/NK-cell lymphomas, unspecified spleen

C84.98

Mature T/NK-cell lymphomas, unspecified lymph nodes of multiple sites

C84.99

Mature T/NK-cell lymphomas, unspecified extranodal and solid organ sites

C84.Z0

Other mature T/NK-cell lymphomas unspecified site

C84.Z1

Other mature T/NK-cell lymphomas lymph nodes of head, face, and neck

C84.Z2

Other mature T/NK-cell lymphomas intrathoracic lymph nodes

C84.Z3

Other mature T/NK-cell lymphomas intra-abdominal lymph nodes

C84.Z4

Other mature T/NK-cell lymphomas lymph nodes of axilla and upper limb

C84.Z5

Other mature T/NK-cell lymphomas lymph nodes of inguinal region and lower limb

C84.Z6

Other mature T/NK-cell lymphomas intrapelvic lymph nodes

C84.Z7

Other mature T/NK-cell lymphomas spleen

C84.Z8

Other mature T/NK-cell lymphomas lymph nodes of multiple sites

C84.Z9

Other mature T/NK-cell lymphomas 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-abdomnal 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

C85.99

Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites

C86.0

Extranodal NK/T-cell lymphoma, nasal type

C86.1

Hepatosplenic T-cell lymphoma

C86.2

Enteropathy-type (intestinal) T-cell lymphoma

C86.4

Blastic NK-cell lymphoma

C86.5

Angioimmunoblastic T-cell lymphoma

C88.0

Waldenström macroglobulinemia

C91.00

Acute lymphoblastic leukemia not having achieved remission

C91.01

Acute lymphoblastic leukemia, in remission

C91.02

Acute lymphoblastic leukemia, in relapse

C91.10

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

C91.12

Chronic lymphocytic leukemia of B-cell type in relapse

C91.50

Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission

C91.51

Adult T-cell lymphoma/leukemia (HTLV-1-associated) in remission

C91.52

Adult T-cell lymphoma/leukemia (HTLV-1-associated) in relapse

D09.0

Carcinoma in situ of bladder

D15.0

Benign neoplasm of thymus

D37.1

Neoplasm of uncertain behavior of stomach

D37.8

Neoplasm of uncertain behavior of other specified digestive organs

D37.9

Neoplasm of uncertain behavior of digestive organ, unspecified

D38.4

Neoplasm of uncertain behavior of thymus

D39.2

Neoplasm of uncertain behavior of placenta

D47.Z1

Post-transplant lymphoproliferative disorder (PTLD)

E16.1

Other hypoglycemia

E16.3

Increased secretion of glucagon

E16.8

Other specified disorders of pancreatic internal secretion

O01.9

Hydatidiform mole, unspecified

Z85.00

Personal history of malignant neoplasm of unspecified digestive organ

Z85.01

Personal history of malignant neoplasm of esophagus

Z85.028

Personal history of other malignant neoplasm of stomach

Z85.038

Personal history of other malignant neoplasm of large intestine

Z85.068

Personal history of other malignant neoplasm of small intestine

Z85.07

Personal history of malignant neoplasm of pancreas

Z85.09

Personal history of malignant neoplasm of other digestive organs

Z85.238

Personal history of other malignant neoplasm of thymus

Z85.43

Personal history of malignant neoplasm of ovary

Z85.51

Personal history of malignant neoplasm of bladder

Z85.72

Personal history of non-Hodgkin lymphomas

Z85.830

Personal history of malignant neoplasm of bone

Z85.858

Personal history of malignant neoplasm of other endocrine glands

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 (applicable to existing NCD/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

 

 

 

 

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