LCD/NCD Portal

L29180

 

G-CSF (FILGRASTIM, NEUPOGEN®)

 

 

02/02/2009

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Medicare will consider G-CSF medically reasonable and necessary for the following FDA approved indications when it is not self/caregiver administered:

• Cancer patients:

o Bone marrow transplant (BMT):

 To reduce the severity of neutropenia in patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by autologous BMT.

o Peripheral Blood Progenitor Cell (PBPC) Collection:

 For use in the mobilization of peripheral stem cells when the bone marrow transplant procedure itself is a covered benefit.

o Progenitor- cell transplantation:

 As an adjunct to allogeneic and autologous progenitor-cell transplantation, both for mobilization of PBPC and as a means to speed hematopoietic reconstitution following BMT or PBPC transplantation.

o Neutrophil engraftment failure:

 To assist in the recovery of patients who experience delayed or inadequate neutrophil engraftment following progenitor-cell transplantation.

o Myelosuppressive chemotherapy:

 To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe febrile neutropenia.

o Acute myelogenous leukemia (AML):

 To reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML.

• Severe chronic neutropenia (SCN) patients:

o Congenital.

o Cyclic.

o Idiopathic neutropenia.

o To reduce the incidence and duration of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with SCN.

• Medicare will consider G-CSF medically reasonable and necessary for the following off-label indications when it is not self/caregiver administered:

o AIDS leukopenia in children.

o Amelioration of leukopenia in AIDS patients on AZT.

o Amelioration of leukopenia in AIDS patients with chorioretinitis on Ganciclovir.

o Intermittent administration of G-CSF for a subset of patients with myelodysplastic syndromes (MDS) who have severe neutropenia and recurrent infections.

Limitations

• A physician is not to bill Medicare for a supply of G-CSF given to the patient for self-administration at home.

• The following unlabeled uses of G-CSF have NOT been shown to be safe and effective and are noncovered by Medicare:

o Aplastic anemia.

o Hairy cell leukemia.

o Myeloid malignancies (other than AML).

o Drug-induced and congenital agranulocytosis.

o Alloimmune neonatal neutropenia.

• Therapeutic initiation of G-CSF does not add significantly to the antibiotic treatment outcome of established febrile neutropenia. Exceptions to this rule must be documented.

• There are inadequate data to support the use of G-CSF for patients with afebrile neutropenia.

• In general, for previously untreated patients receiving a chemotherapy regimen, primary administration of G-CSF is not considered medically necessary.

• G-CSF should not be given within 24 hours before or after a dose of a chemotherapeutic agent, as rapidly dividing myeloid cells are potentially sensitive to these agents.

• There is no evidence of benefit from the use of G-CSF to increase chemotherapy dose-intensity.

• G-CSF should not be used concurrently with radiation therapy.

Dosage and Frequency

• The package insert instructions for dosage and duration of treatment should not be exceeded.

• The following is the recommended dosage and frequency when administering this drug:

o BMT

 Recommended dose following BMT is 10 mcg/kg/day given as an IV infusion of 4 or 24 hours or SC.

 The first dose should be administered at least 24 hours after chemotherapy and at least 24 hours after bone marrow infusion.

 The dose should be based on the neutrophil response.

 When the absolute neutrophil count (ANC) is >1000/mm³ for 3 consecutive days, reduce the G-CSF dosage to 5 mcg/kg/day.

 If the ANC remains >1000/mm³ for 3 more consecutive days, discontinue use.

o PBPC

 Recommended dose is 10 mcg/kg/day SC. G-CSF should be given for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis.

o Myelosuppressive chemotherapy

 Recommended starting dose is 5 mcg/kg/day SC or short IV infusion (15-30 minutes), or by continuous infusion.

 Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle, according to duration and severity of the ANC nadir.

 Administer no earlier than 24 hours after cytotoxic chemotherapy and not in the 24 hours before administration of chemotherapy.

 The drug should be discontinued when the absolute neutrophil count (ANC) reaches 10,000/mm³ and/or the patient becomes afebrile, or the patient has received the drug for a maximum of 14 days per treatment regimen.

o AML

 Recommended starting dose is 5mcg/kg/day SC until:

• ANC ³ 1,000 cells/mm³ for 3 days.

• ANC > 10,000 cells/mm³ for 1 day or for a maximum of 35 days.

o SCN

 Starting dose for congenital neutropenia is 6 mcg/kg twice daily SC every day.

 Idiopathic or cyclic neutropenia starting dose is 5 mcg/kg as a single injection SC every day.

 Chronic daily administration is required to maintain clinical benefit. Individually adjust the dose based on the patient’s clinical course, as well as the ANC.

 Reduce the dose if the ANC is persistently > 10,0000/mm³.

o **The guidelines recommended for adults are generally applicable to the pediatric age group.

 

 

CPT/HCPCS Codes

 

J1440 INJECTION, FILGRASTIM (G-CSF), 300 MCG

J1441 INJECTION, FILGRASTIM (G-CSF), 480 MCG

 

 

ICD-9 Codes that Support Medical Necessity

 

238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION

238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED

238.77 POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD)

288.00 NEUTROPENIA, UNSPECIFIED

288.01 CONGENITAL NEUTROPENIA

288.02 CYCLIC NEUTROPENIA

288.03 DRUG INDUCED NEUTROPENIA

288.04 NEUTROPENIA DUE TO INFECTION

288.09 OTHER NEUTROPENIA

995.20 UNSPECIFIED ADVERSE EFFECT OF UNSPECIFIED DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE

995.29 UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE

V42.81* BONE MARROW REPLACED BY TRANSPLANT

V42.82* PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT

V42.9 UNSPECIFIED ORGAN OR TISSUE REPLACED BY TRANSPLANT

V58.11 ENCOUNTER FOR ANTINEOPLASTIC CHEMOTHERAPY

V58.69* LONG-TERM (CURRENT) USE OF OTHER MEDICATIONS

V59.8 DONORS OF OTHER SPECIFIED ORGAN OR TISSUE

* According to the ICD-9-CM book, diagnosis code V58.69 is a secondary diagnosis code and should not be billed as the primary diagnosis. For V42.81 and V42.82 the underlying condition should be billed as the primary diagnosis code.

 

 

Documentation Requirements

 

• Medical record documentation maintained by the physician must clearly indicate:

o The patient’s current absolute neutrophil count (ANC).

o The patient’s weight in kilograms.

o The administration and dosage of the G-CSF.

o The actual indication for which the drug was given and accompanying symptomology (e.g., fever)

o The patient’s response to the treatment.

• This information is usually found in the history and physical or the office/progress notes.

Treatment Logic

• G-CSF is classified as a recombinant hematopoietic stimulant.

• This is not a cancer chemotherapy agent. It is a class II hematopoietic growth factor which acts on progenitor cells capable of forming a single differentiated cell type, the neutrophilic granulocyte, and is thus lineage-specific.

• Because Filgrastim acts only on progenitor cells that are already committed to one pathway, it increases only the neutrophil (e.g., granulocyte) count.

 

 

Sources of Information and Basis for Decision

 

American Society of Clinical Oncology Growth Factor Expert Panel. (2000). Update recommendations for the use of hematopoietic colony-stimulating factors: Evidence-based, clinical practice guidelines. Retrieved from the world wide web: http://www.asco.org/cgi/content/full/18/20/3558. This source provided information for the indications section of the policy.

 

Fauci, A.S., Braunwald, E., Isselbacher, K.J., et. al. (2004). Harrison’s Principles of Internal Medicine (16d.). New York: McGraw-Hill.

 

FCSO LOCD 291180, G-CSF (Filgrastim, Neupogen®), 02/02/2009. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Fischbach, F.T. (2003). A Manual of Laboratory and Diagnostic Tests (6th ed.). Philadelphia: J.B. Lippincott Company.

 

Package Insert Neupogen® (Filgrastim). (2002). Amgen Inc.

 

Physician Desk Reference 2004

 

The United States Pharmacopoeia Drug Information (USPDI). (2002). Oncology drug information. Maryland: The Association of Community Cancer Centers (ACCC). [on-line]. Available: http://www.acc-cancer.org/cgi-bin/nds/nvbcgfh.exe.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD L29180 G-CSF (FILGRASTIM, NEUPOGEN®)