• The Food and Drug Administration (FDA) approved rG-CSF to decrease the incidence of neutropenia in patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation.
  • It is FDA-approved for use in severe symptomatic chronic neutropenia. This includes congenital neutropenias, cyclic neutropenias and idiopathic neutropenias. It is FDA-approved for the prevention of infection as manifested by febrile neutropenia in patients treated with cytotoxic chemotherapy from which a high incidence of associated febrile neutropenia, associated with its administration, can be anticipated in a given patient.
  • It is also approved for the use in mobilization of peripheral stem cells when the transplant procedure itself is a covered benefit.
  • Myelodysplastic syndromes may also constitute a clinical indication, given proper documentation of such a pathologic diagnosis.
  • There is no good evidence that rG-CSF adds significantly to the antibiotic treatment outcome of already established febrile neutropenia in most patients.
  • When treating chronic neutropenias, the drug may need to be given daily for long periods of time. At least one manufacturer has a program to supply the drug for free for a period of five years. Supplies incident to its administration would be non-covered. However, a physician’s care would be a covered benefit.
  • Use of sargramostim, as a single agent or in combination therapy, for the treatment of melanoma has not been established. (USPDI)
Dosage and Frequency
It is recommended that the drug be used until the desired neutrophil level is reached or for a maximum of 14 days. Dosage is per the package insert.
Granulocyte-Macrophage Colony Stimulating Factor: Sargramostim {GM-CSF} (Leukine®, Prokine®)
GM-CSF, a white blood cell stimulant, is a yeast-derived granulocyte-macrophage colony stimulating factor. It is used:
  • To facilitate bone marrow recovery after autologous marrow transplants for non-myeloid malignancies or after autologous/allogeneic bone marrow transplants that are failing or where recovery is delayed when the transplant procedure itself is a covered benefit.
  • To shorten neutrophil recovery time in patients 55 years of age and older with Acute Myeloid Leukemia (AML).
  • To assist in marrow recovery following the use of autologous peripheral stem cell transplants for non-myeloid disorders when the transplant procedure itself is a covered benefit.
  • To be used as a primer for collection of autologous peripheral stem cells in patients with non-myeloid disorders when the transplant procedure itself is a covered benefit.
  • To serve as a primer for collection of allogeneic peripheral stem cells to be used in Medicare-approved stem cell transplants when the transplant procedure itself is a covered benefit.
  • To be used for severe chronic neutropenia.
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.
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, then 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. Refer 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.
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, 18X, 21X, 22X, 23X, 71X, 72X, 73X, 74X, 75X, 77X, 83X, 85X
Bill Type Note: Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.
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 LCD. 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.
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, filgrastim (G-CSF), 300 mcg
Injection, filgrastim (G-CSF), 480 mcg
Injection, pegfilgrastim, 6 mg
Injection, sargramostim (GM-CSF), 50 mcg
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 J1440, J1441, J2505 and J2820:
Covered for:
Other lymphatic and hematopoietic tissues
Other neutropenia
Neutropenic splenomegaly
Trspl sts-perip stm cell
Organ or tissue replaced by unspecified organ or tissue
Note: Use V42.9* to indicate rG-CSF is given to stem cell recipients.
Blood donor – stem cells
Donors bone marrow
Donors other specified organ or tissue
Note: Use V59.8* to indicate used in priming for autologous peripheral stem cells.
Convalescence following chemotherapy
Convalescence and palliative care following other treatment
Note: Use V66.5* to indicate the patient has AZT or ganciclovir neutropenia.
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.
Medical records must document the chemotherapy agent which caused the febrile neutropenia.
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.