- 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)
- 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.
- 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.
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
Other lymphatic and hematopoietic tissues
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.
- Date and time.
- Amount of medication wasted.
- Reason for the wastage.