Asset Publisher
Levoleucovorin: Fusilev®; Khapzory™
Policy Number: PH-0183
Intravenous
Last Review Date: 03/02/2023
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
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. |
- Length of Authorization
Coverage will be provided for ninety (90) days and may be renewed.
- Dosing Limits
A. Quantity Limit (max daily dose) [NDC Unit]:
Fusilev
- Fusilev 50 mg single-dose vial for injection: 25 vials per 28 days
- Fusilev 175 mg/17.5 mL single-dose vial for injection: 8 vials per 28 days
- Fusilev 250 mg/25 mL single-dose vial for injection: 5 vials per 28 days
Khapzory
- Khapzory 175 mg single-dose vial for injection: 8 vials per 28 days
- Khapzory 300 mg single-dose vial for injection: 4 vials per 28 days
B. Max Units (per dose and over time) [HCPCS Unit]:
In combination with methotrexate or for inadvertent overdosage
- 1,200 billable units every 28 days
In combination with fluorouracil
- 2,500 billable units every 28 days
- Initial Approval Criteria
Coverage is provided in the following conditions:
- Patient is at least 6 years of age; AND
Universal Criteria
- 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) ‡
- 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 †
- 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 ‡
- Must be used in combination with fluorouracil-based regimens
Gestational Trophoblastic Neoplasia ‡
- Used in combination with a methotrexate-based regimen
Used in combination with high-dose methotrexate for the following ‡:
- Acute Lymphoblastic Leukemia/Pediatric Acute Lymphoblastic Leukemia
- Adult T-cell Leukemia/Lymphoma
- HIV-related B-cell Lymphoma
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- Burkitt Lymphoma
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- CNS Cancer (Primary CNS Lymphoma, Brain Metastases, & Leptomeningeal Metastases)
- Diffuse Large B-Cell Lymphoma
- Extranodal NK/T-cell Lymphoma (nasal type)
- Hepatosplenic T-Cell Lymphoma
- High Grade B-Cell Lymphomas
- Mantle Cell Lymphoma
- Pediatric Aggressive Mature B-Cell Lymphomas
- Peripheral T-cell Lymphoma
- Post-Transplant Lymphoproliferative Disorders (PTLD)
- Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma (Used for the management of symptomatic Bing-Neel syndrome)
Used in combination with fluorouracil-based regimens for the following ‡:
- Ampullary Adenocarcinoma
- Anal Carcinoma
- Bladder Cancer (Non-Urothelial and Urothelial with Variant Histology)
- Cervical Cancer
- Esophageal, Esophagogastric Junction, & Gastric Cancer
- Gallbladder Cancer, Extrahepatic Cholangiocarcinoma, and Intrahepatic Cholangiocarcinoma
- Neuroendocrine and Adrenal Tumors (Poorly Differentiated - High Grade/Large or Small Cell/Mixed Neuroendocrine-Non-Neuroendocrine/Well-Differentiated Grade 1-3 & Tumors of the Pancreas)
- Occult Primary
- Ovarian-Epithelial/Fallopian Tube/Primary Peritoneal/Mucinous Carcinomas
- Pancreatic Adenocarcinoma
- Small Bowel Adenocarcinoma
- Thymoma and Thymic Carcinoma
† FDA labeled indication(s); ‡ Compendia recommended indication(s); Φ Orphan Drug
- Renewal Criteria
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, seizures, and severe gastrointestinal disorders (i.e., stomatitis, severe diarrhea, and severe nausea and vomiting); AND
- Patient is responding to therapy
- Dosage/Administration
Indication |
Dose |
In combination with methotrexate (MTX) |
|
Reduction of toxicity due to impaired elimination or inadvertent overdose with folic acid antagonists |
|
In combination with fluorouracil (5-FU) |
OR
Alternate Dosing Regimen
|
Note: Levoleucovorin is dosed at one-half the usual dose of racemic d,l-leucovorin |
- Billing Code/Availability Information
HCPCS Code:
- 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 *§
* generics available through various manufacturers
§ brand name no longer commercially available
- Khapzory 175 mg single-dose vial powder for injection: 72893-0004-xx
- Khapzory 300 mg single-dose vial powder for injection: 72893-0006-xx
- References
- Fusilev [package insert]. East Windsor, NJ; Acrotech Biopharma LLC; November 2020. Accessed February 2023.
- Khapzory [package insert]. East Windsor, NJ; Acrotech Biopharma LLC; March 2020. Accessed February 2023.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) levoleucovorin. 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 February 2023.
- 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 |
C18.9 |
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 |
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 |
C83.50 |
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 |
Z85.07 |
Personal history of malignant neoplasm of pancreas |
Z85.09 |
Personal history of malignant neoplasm of other digestive organs |
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 |
Z85.238 |
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 |
Z85.830 |
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)
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) 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/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 |
LEVOLEUCOVORIN (Fusilev®; Khapzory™) Prior Auth Criteria |
|