Leucovorin and Levoleucovorin calcium are indicated:
  • As an antidote to the toxic effects of folic acid antagonists such as methotrexate, pyrimethamine, trimetrexate or trimethoprim.
  • As a rescue agent after high-dose methotrexate therapy in several malignancies, such as osteosarcoma.
  • To treat megaloblastic anemias associated with sprue, nutritional deficiency, pregnancy and infancy when oral folic acid therapy is not feasible.
  • In combination with fluorouracil to prolong survival in the treatment of patients with advanced colorectal cancer.
Leucovorin and Levoleucovorin are not recommended in the treatment of pernicious anemia or other megaloblastic anemias secondary to the lack of vitamin B-12.
Note: Advanced colorectal cancer would be considered as a colon cancer that has invaded beyond the muscular layers of the colon wall or has lymph node involvement (i.e., a primary tumor that is beyond a Duke’s Class A tumor).
Drug Wastage
Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good-faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug and made good-faith efforts to minimize the unused portion of the drug in how it is supplied, the program will cover the amount of drug discarded along with the amount administered. Documentation requirements are given below. Coding and billing instructions can be referenced in the attached article. Reference to national policy:Medicare Claims Processing Manual – Pub. 100-04, Chapter 17, Section 40.
Note: The JW modifier is not used on claims for drugs or biologicals provided under the Competitive Acquisition Program (CAP). Reference to national policy: Medicare Claims Processing Manual, Pub. 100-04, Chapter 17, Section 100.2.9.
Note: This LCD and the related Article do NOT describe drug and biological coverage under the Medicare Part D benefit.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.

Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 21X, 23X, 71X, 75X, 83X, 85X
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this policy. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.
022X, 0250, 0636
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
Injection, leucovorin calcium, per 50 mg
Injection, levoleucovorin calcium, 0.5 mg
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes J0640 and J0641:
Covered for:
Malignant neoplasm of lip
Malignant neoplasm of lip
Malignant neoplasm of lip
Malignant neoplasm of tongue
Malignant neoplasm of tongue
Malignant neoplasm of major salivary glands
Malignant neoplasm of major salivary glands
Malignant neoplasm of gum
Malignant neoplasm of gum
Malignant neoplasm of floor of mouth
Malignant neoplasm of floor of mouth
Malignant neoplasm of other and unspecified parts of mouth
Malignant neoplasm of other and unspecified parts of mouth
Malignant neoplasm of oropharynx
Malignant neoplasm of nasopharynx
Malignant neoplasm of nasopharynx
Malignant neoplasm of hypopharynx
Malignant neoplasm of hypopharynx
Malignant neoplasm of other and ill-defined sites
Malignant neoplasm of other and ill-defined sites
Malignant neoplasm of esophagus
Malignant neoplasm of esophagus
Malignant neoplasm of colon
Malignant neoplasm of rectum, rectosigmoid junction, and anus
Malignant neoplasm of rectum, rectosigmoid junction and anus, other
Malignant neoplasm of larynx
Malignant neoplasm of larynx
Malignant neoplasm of bone and articular cartilage
Other malignant neoplasm of skin
Malignant neoplasm of placenta
Malignant neoplasm of other and unspecified testis
Malignant neoplasm of other and ill-defined sites, head, neck and face
Burkitt’s tumor or lymphoma
Marginal zone lymphoma
Mantle cell lymphoma
Primary central nervous system lymphoma
Anaplastic large cell lymphoma
Large cell lymphoma
Lymphosarcoma and reticulosarcoma, other named variants
Nodular lymphoma
Mycosis fungoides
Sezary’s disease
Malignant histiocytosis
Leukemic reticuloendotheliosis
Letterer-Siwe disease
Malignant mast cell tumors
Peripheral T cell lymphoma
Other lymphomas
Other malignant neoplasms of lymphoid and histiocytic tissue
Neoplasm of uncertain behavior of placenta
Other deficiency anemias
Open-angle glaucoma
Glaucoma associated with systemic syndromes
Poisoning by other anti-infectives, anti-malarials and drugs acting on other blood protozoa
Other and unspecified anti-infectives
Poisoning by primarily systemic agents, anti-neoplastic, and immunosuppressive drugs
Note: Use 963.1 when Leucovorin or Levoleucovorin is used to counter the toxic effects of methotrexate.
Personal history of malignant neoplasm large intestine, rectum, rectosigmoid junction, and anus
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
ICD-9-CM Codes That DO NOT Support Medical Necessity
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
Drug Wastage Documentation Requirements
Any amount wasted must be clearly documented in the medical record, regardless of whether the JW modifier will be used in billing for the drug/biological, with:
  • Date and time.
  • Amount of medication wasted.
  • Reason for the wastage.
Utilization Guidelines
When the five-day-a-week 5FU protocol is used, 20 mg/m2/day would be considered the upper limit for dosage, and when the 500 mg/m2/week protocol is given as a weekly dosage, that would be considered as the upper limit for dosage.
Notice: This LCD imposes utilization guideline limitations. Despite Medicare’s allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.