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Asset Publisher
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. |
- Length of Authorization 1-3
Coverage will be provided for 90 days and may be renewed.
- Dosing Limits
- 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
- 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
- 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
- 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
- Dosage/Administration 1-2
Indication |
Dose |
In combination with methotrexate (MTX) |
|
Reduction of toxicity due to impaired elimination of MTX or inadvertent overdose with folic acid antagonists |
|
In combination with fluorouracil (5-FU) |
OR
Alternate Dosing Regimen
|
- 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 |
- References
- Fusilev [package insert]. East Windsor, NJ; Acrotech Biopharma LLC; November 2020. Accessed January 2024.
- Khapzory [package insert]. East Windsor, NJ; Acrotech Biopharma LLC; March 2020. Accessed January 2024.
- 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.
- 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 |
LEVOLEUCOVORIN (Fusilev®; Khapzory™) Prior Auth Criteria |
|