Human Granulocyte/Macrophage Colony Stimulating Factors (L30306)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402
Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L30306

LCD Title
Human Granulocyte/Macrophage Colony Stimulating Factors

Contractor's Determination Number
INJ-019

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.

Primary Geographic Jurisdiction


Oversight Region



Original Determination Effective Date
For services performed on or after 09/15/2009

Original Determination Ending Date


Revision Effective Date
For services performed on or after 11/01/2011

Revision Ending Date


CMS National Coverage Policy
Medicare Benefit Policy Manual: PUB 100-2 Chapter 15
Medicare Claims Processing Manual: PUB 100-4 Chapter 17
Indications and Limitations of Coverage and/or Medical Necessity
A. Human granulocyte colony-stimulating factors (Filgrastim and Pefilgastrim) are drugs that are produced by recombinant DNA technology with the use of bacteria and a human G-CSF gene. G- CSF regulates the production of neutrophils (a WBC) within the bone marrow (where blood cells are manufactured naturally in the body). Neutrophils are an essential in the body's fight against infections.

B. Granulocyte macrophage colony-stimulating factor (Sargramostim) is a recombinant human granulocyte-macrophage colony-stimulating factor produced by recombinant DNA technology in yeast. Granulocytes and macrophage cells (WBC's) are essential in the body's fight against infections.

C. Indications for Filgrastim (Neupogen TM) (J1440, J1441):
1. To decrease the incidence of infection as manifested by febrile neutropenia, for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (288.03)

2. Administration may be indicated for patients at high risk for chemotherapy-induced infectious complications. Such risk factors may include the following (V15.9) and should be documented in the patient record:
a. Pre-existing neutropenia due to disease,
b. Extensive prior chemotherapy
c. Previous irradiation to the pelvis or other areas containing large amounts of bone marrow.
d. A history of recurrent febrile neutropenia while receiving earlier chemotherapy of similar or lesser dose-intensity
e. Conditions potentially enhancing the risk of serious infection.

3. To reduce the duration of neutropenia and neutropenia related clinical sequelae (febrile neutropenia) for patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplant. (V42.81).

4. Peripheral Blood Progenitor Cell (PBPC) Collection (V42.82)-For the mobilization of hematopoietic progenitor cells into the peripheral blood for leukapheresis collection. Mobilization allows for collection of increased progenitor cell numbers capable of engraftment compared with collection by leukapheresis without mobilization or bone marrow harvest. After myeloablative chemotherapy, the transplantation of an increased number of progenitor cells can lead to more rapid engraftment, decreasing the need for supportive care.

5. Severe chronic neutropenia: chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg. fever, infections, and oropharyngeal ulcers) in symptomatic patients with congenital, cyclic or idiopathic neutropenia (288.00, 288.01, 288.02)

6. Patients with Acute Myeloid Leukemia (AML) (205.00, 205.02) receiving induction or consolidation chemotherapy

7. Acquired immunodeficiency syndrome (AIDS) patients with neutropenia caused by the disease itself or by opportunistic infections (042)

8. Severe aplastic anemia (284.89)

9. Hairy cell leukemia (202.40-202.48)

10. Myelodysplastic syndrome (238.72-238.76). It is not recommended for routine infection prophylaxis. Consider use if recurrent or resistant infections in neutropenic patients.

11. Drug induced or congential agranulocytosis, alloimmune neonatal neutropenia (288.03 or 288.01).

12. Prophylactically used to decrease the incidence of infection, for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of febrile neutropenia (V07.8)


D. Indications for Sargramostim (Leukine TM) (J2820):
1. To decrease the incidence of infection as manifested by febrile neutropenia, for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (288.03).

2. Acceleration of myeloid recovery in patients with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's disease undergoing autologous bone marrow transplantation (BMT).

Indicate this by coding the BMT (V42.81) and NHL (202.00-202.08, 202.80-202.88) or ALL (204.00, 204.02) or Hodgkin's disease (201.40-201.98).

3. Bone Marrow Transplant failure or engraftment delay. For patients who have undergone allogeneic or autologous BMT in whom engraftment is delayed or has failed (996.85).

4. Induction chemotherapy in acute myelogenous leukemia (AML).
The acceleration of neutrophil recovery following induction of chemotherapy in the treatment of patients over the age of 55-years old with acute myelogenous leukemia. Safety and efficacy has not been established in AML patients less than 55 years of age. Use the ICD-9 code 288.03 to identify drug-induced neutropenia and the code 205.00 or 205.02 to indicate acute myelogenous leukemia.

5. Mobilization and following transplantation of autologous peripheral blood progenitor cells (V42.82). For mobilization of hematopoietic progenitor cells into peripheral blood collection by leukapheresis. After myeloablative chemotherapy, the transplantation of an increase number of progenitor cells can lead to rapid engraftment which may decrease the need for supportive care.

6. Myeloid reconstitution after allogenic bone marrow transplant (BMT) (V42.81): For acceleration of myeloid recovery in patient's undergoing allogeneic BMT from human lymphocyte antigen (HLA) matched related donors. Safety and efficacy has been established in accelerating myeloid engraftment, reducing the incidence of bacteremia and other culture positive infections.

7. To increase WBC counts in patients with myelodysplastic syndromes (238.72-238.76).

8. Acquired Immunodeficiency Syndrome (AIDS) (042) patients receiving zidovudine.

9. To decrease nadir of leukopenia secondary to myelosuppressive chemotherapy and decrease myelosuppression in preleukemic patients (238.72-238.76).

10. To correct neutropenia in aplastic anemia patients (284.89).

11. Drug induced or congenital agranulocytosis, alloimmune neonatal neutropenia (288.03 or 288.01).

12. Prophylactically used to decrease the incidence of infection, for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of febrile neutropenia (V07.8)

13. For the adjunct treatment of malignant melanoma (172.0-172.9) following surgery for stage III or IV melanoma for those at high risk for recurrence.


E. Indications for Pegfilgrastim (Neulasta TM): (J2505)
1. To decrease the incidence of infection, as manifested by febrile neutropenia, for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of febrile neutropenia (288.03).

2. Prophylactically used to decrease the incidence of infection, for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of febrile neutropenia (V07.8)

3. Administration may be indicated for patients at high risk for chemotherapy-induced infectious complications. Such risk factors may include the following (V15.9) and should be documented in the patient record:
a. Pre-existing neutropenia due to disease,
b. Extensive prior chemotherapy
c. Previous irradiation to the pelvis or other areas containing large amounts of bone marrow.
d. A history of recurrent febrile neutropenia while receiving earlier chemotherapy of similar or lesser dose-intensity
e. Conditions potentially enhancing the risk of serious infection.


Coding Information

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.

012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
014x Hospital - Laboratory Services Provided to Non-patients
022x Skilled Nursing - Inpatient (Medicare Part B only)
023x Skilled Nursing - Outpatient
071x Clinic - Rural Health
073x Clinic - Freestanding
085x Critical Access Hospital

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.



CPT/HCPCS Codes

J1440INJECTION, FILGRASTIM (G-CSF), 300 MCG
J1441INJECTION, FILGRASTIM (G-CSF), 480 MCG
J2505INJECTION, PEGFILGRASTIM, 6 MG
J2820INJECTION, SARGRAMOSTIM (GM-CSF), 50 MCG

ICD-9 Codes that Support Medical Necessity

Note: ICD-9 codes must be coded to the highest level of specificity.

042HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
172.0 - 172.9MALIGNANT MELANOMA OF SKIN OF LIP - MELANOMA OF SKIN SITE UNSPECIFIED
201.40 - 201.98HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES
202.00 - 202.08NODULAR LYMPHOMA UNSPECIFIED SITE - NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
202.40 - 202.48LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE - LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.80 - 202.88OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE - OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES
204.00ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
204.02ACUTE LYMPHOID LEUKEMIA, IN RELAPSE
205.00ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
205.02ACUTE MYELOID LEUKEMIA, IN RELAPSE
238.72LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS
238.73HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS
238.74MYELODYSPLASTIC SYNDROME WITH 5Q DELETION
238.75MYELODYSPLASTIC SYNDROME, UNSPECIFIED
238.76MYELOFIBROSIS WITH MYELOID METAPLASIA
284.89OTHER SPECIFIED APLASTIC ANEMIAS
288.00NEUTROPENIA, UNSPECIFIED
288.01CONGENITAL NEUTROPENIA
288.02CYCLIC NEUTROPENIA
288.03DRUG INDUCED NEUTROPENIA
996.85COMPLICATIONS OF TRANSPLANTED BONE MARROW
V07.8OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE
V15.9UNSPECIFIED PERSONAL HISTORY PRESENTING HAZARDS TO HEALTH
V42.81BONE MARROW REPLACED BY TRANSPLANT
V42.82PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity
Any ICD-9 code not listed above

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentations Requirements
Medical necessity documentation for the use of these drugs must be clearly described in the patient's medical record, and be available, upon request, for verification and review. Documentation should not be submitted with each claim.

The medical record should indicate the patient is on a 14 day dose dense chemotherapy cycle.
Appendices
Utilization Guidelines
Coverage for this medication is based on the patient's condition, the appropriateness of the dose and route of administration, based on the clinical condition and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition. The drug must be administered at a frequency that is supported in the medical literature.

Dose dense chemotherapy treatment schedules and other chemotherapy regimens with cycle intervals of less than 3 weeks, such as those with 2 week intervals, will be allowed where literature supports its use.
Sources of Information and Basis for Decision
Smith TJ, Khatcheressian K, Lyman GH, et al: "2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline", Journal of Clinical Oncology, Vol. 24, No 19 (July 1), 2006:pp. 3187-3205

National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology-Myeloid Growth Factors V.1.2009

ASCO Guidelines hematopoietic -colony stimulating growth factors

Drug Facts and Comparisons,
Physicians' Desk Reference (PDR).
Manufacture's package inserts,

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from hematology and oncology
Advisory Committee Meeting Notes
Meeting Date:
Wisconsin: 01/16/2009
Illinois: 01/28/2009
Michigan: 01/07/2009
Minnesota: 01/22/2009
J-5 MAC (IA,KS,MO, NE) 02/12/2009

Jurisdictional Open meeting
12/17/08
Start Date of Comment Period
02/12/2009
End Date of Comment Period
07/05/2009
Start Date of Notice Period
06/01/2011
Revision History Number
X
Revision History Explanation
07/24/2009 Revised draft and Released to Final. This policy replaces L19954, L19955, L19956, L19957

Removed contractor 05392 because it is joining with contractor number for W MO effective 08/01/2009 bw

09/16/2009 288.01 added to ICD-9 listing

3/7/2010 - The description for Bill Type Code 73 was changed

04/19/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of American Somoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands were removed from this LCD because claims processing for those states are transitioning from FI Contractor Wisconsin Physician Services (WPS - 52280) to MAC Part A Contractor  Palmetto.

08/01/2010- Clarified our coverage interval. Added other chemotherapy regimens with cycle intervals of less than 3 weeks, such as those with 2 week intervals, will be allowed where literature supports its use under utilization guidelines.

8/1/2010 - The description for Bill Type Code 12 was changed
8/1/2010 - The description for Bill Type Code 13 was changed
8/1/2010 - The description for Bill Type Code 14 was changed
8/1/2010 - The description for Bill Type Code 22 was changed
8/1/2010 - The description for Bill Type Code 23 was changed
8/1/2010 - The description for Bill Type Code 71 was changed
8/1/2010 - The description for Bill Type Code 73 was changed
8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0631 was changed
8/1/2010 - The description for Revenue code 0632 was changed
8/1/2010 - The description for Revenue code 0633 was changed
8/1/2010 - The description for Revenue code 0634 was changed
8/1/2010 - The description for Revenue code 0635 was changed
8/1/2010 - The description for Revenue code 0636 was changed
8/1/2010 - The description for Revenue code 0637 was changed

8/1/2010 - Revenue code 0630 was deleted

09/01/2010- Added 202.00-202.08 to J2820. Removed 063X from Revenue code section

10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).

02/21/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).

06/01/2011-Added -Prophylactically used to decrease the incidence of infection, for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of febrile neutropenia to (V07.8) to (J1440, J1441, J2505, J2820)

11/01/2011- Article published-Added to J2820-indication #13: For the adjunct treatment of malignant melanoma (172.0-172.9) following surgery for stage III or IV melanoma for those at high risk for recurrence.
Reason for Change
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Page Last Updated: Thursday, 03-Nov-2011 13:02:37 CDT