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Article for Filgrastim, Pegfilgrastim, Tbo-filgrastim and biosimilars - Related to LCD L33394 (A52408)


Contractor Information

Contractor Name Contract Type Contract Number Jurisdiction State(s)
National Government Services, Inc. MAC - Part A 06101 - MAC A J - 06 Illinois
National Government Services, Inc. MAC - Part B 06102 - MAC B J - 06 Illinois
National Government Services, Inc. MAC - Part A 06201 - MAC A J - 06 Minnesota
National Government Services, Inc. MAC - Part B 06202 - MAC B J - 06 Minnesota
National Government Services, Inc. MAC - Part A 06301 - MAC A J - 06 Wisconsin
National Government Services, Inc. MAC - Part B 06302 - MAC B J - 06 Wisconsin
National Government Services, Inc. A and B and HHH MAC 13101 - MAC A J - K Connecticut
National Government Services, Inc. A and B and HHH MAC 13102 - MAC B J - K Connecticut
National Government Services, Inc. A and B and HHH MAC 13201 - MAC A J - K New York - Entire State
National Government Services, Inc. A and B and HHH MAC 13202 - MAC B J - K New York - Downstate
National Government Services, Inc. A and B and HHH MAC 13282 - MAC B J - K New York - Upstate
National Government Services, Inc. A and B and HHH MAC 13292 - MAC B J - K New York - Queens
National Government Services, Inc. A and B and HHH MAC 14111 - MAC A J - K Maine
National Government Services, Inc. A and B and HHH MAC 14112 - MAC B J - K Maine
National Government Services, Inc. A and B and HHH MAC 14211 - MAC A J - K Massachusetts
National Government Services, Inc. A and B and HHH MAC 14212 - MAC B J - K Massachusetts
National Government Services, Inc. A and B and HHH MAC 14311 - MAC A J - K New Hampshire
National Government Services, Inc. A and B and HHH MAC 14312 - MAC B J - K New Hampshire
National Government Services, Inc. A and B and HHH MAC 14411 - MAC A J - K Rhode Island
National Government Services, Inc. A and B and HHH MAC 14412 - MAC B J - K Rhode Island
National Government Services, Inc. A and B and HHH MAC 14511 - MAC A J - K Vermont
National Government Services, Inc. A and B and HHH MAC 14512 - MAC B J - K Vermont

Article Information

General Information

Article ID

A52408

Original ICD-9 Article ID

A48208

Article Title

Filgrastim, Pegfilgrastim, Tbo-filgrastim and biosimilars - Related to LCD L33394

Original Article Effective Date

10/01/2015

Revision Effective Date

08/01/2019

Revision Ending Date

N/A

Retirement Date

N/A

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

PT codes, descriptions and other data only are copyright 2018 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Current Dental Terminology © 2018 American Dental Association. All rights reserved.

Copyright © 2018, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816 or Laryssa Marshall at (312) 893-6814. You may also contact us at ub04@healthforum.com.

Article Guidance

Article Text:

This article defines coding and coverage for filgrastim, pegfilgrastim, Tbo-filgrastim and filgrastim-sndz including on and off-label indications. National Government Services Local Coverage Determination (LCD) "Coverage of Drugs and Biologicals for Label and Off-Label Uses" accessible via www.NGSMedicare.com or www.cms.gov/medicare-coverage-database) provides criteria for coverage of off-label indications based on the American Hospital Formulary Services (AHFS), Clinical Pharmacology, NCCN Drugs and Biologics Compendium, Micromedex DrugDex® and/or Lexi-Drugs compendium. Providers may request approval for additional off-label indications by submitting this request in writing with supporting medical literature.

Abstract:

Filgrastim is a human granculocyte colony stimulating factor (G-CSF), produced by recombinant DNA technology.

Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol.

Filgrastim and pegfilgrastim are CSFs that act on hematopoietic cells by binding to specific cell surface receptors thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

G-CSF regulates the production of neutrophils in the bone marrow. Neutrophils are essential in the body's fight against infections.

Tbo-filgrastim is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802.

 Indications:

Filgrastim, filgrastim-sndz and filgrastim-aafi are covered (FDA approved or recognized off label) for the following uses:

    • in mobilization of peripheral stem cells when the transplant procedure is a covered benefit,
    • for the prevention of infection, as manifest by febrile neturopenia in patients treated with cytotoxic chemotherapy, for which a high incidence of associated febrile neutropenia, can be anticipated in a given patient. In addition, to the regimen itself this may include the following factors:
      1. extensive prior chemotherapy/radiation therapy
      2. poor performance status
      3. prior episode of infection after chemotherapy in the absence of significant leucopenia
      4. prior significant leukopenia after chemotherapy in the absence of infection,
    • for AIDS leukopenia in children when not self-administered or administered by a care giver,
    • for amelioration of leukopenia in AIDS patients on AZT (zidovudine) when not self-administered or administered by a care giver,
    • for amelioration of leukopenia in AIDS patients with CMV chorioretinitis on Ganciclovir when not self-administered or administered by a care giver,
    • to decrease the incidence of neutropenia in patients with non-myeloid malignancies undergoing myeloablative chemotherapy, followed by bone marrow transplantation,
    • for febrile neutropenia, including congenital neutropenia, cyclic neutropenia, and idiopathic neutropenia,
    • to enhance neutrophil function in patients with myelodysplastic syndrome and a history of infection,
    • to enhance neutrophil function in patients with aplastic anemia,
    • to enhance neutrophil function in patients with drug induced and congenital agranulocytosis,
    • to enhance neutrophil function in patients with acute myeloid leukemia (AML), and
    • for treatment of drug induced neutropenia [e.g., the patient is receiving pentamidine (pentam) for treatment of pneumocystis pneumonia and develops neutropenia]
    • for treatment of mucositis following chemotherapy
    • for treatment of neutropenia of pre-eclampsia
    • for patients who present with acute exposure to myelosuppressive doses of radiation
    • hematopoietic cell transplant for
      • mobilization of hematopoietic progenitor cells in combination with plerixafor in the autologous setting for patients with non-Hodgkin lymphoma or multiple myeloma
      • mobilization of donor hematopoietic progenitor cells (preferred) or for granulocyte transfusion in the allogeneic setting
      • supportive care in the post-transplant setting

Pegfilgrastim, pegfilgrastim-jmdb and pegfilgrastim-cbqv are covered for the following uses:

    • to decrease the incidence of infection, as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive cancer drugs.
    • Prophylaxis of chemotherapy-induced febrile neutropenia or other neutropenic events compromising treatment in high-risk patients (greater than 20% risk of febrile neutropenia) with solid tumors and non-myeloid malignancies receiving:
      • curative or adjuvant chemotherapy treatment
      • chemotherapy to prolong survival and improve quality of life
      • chemotherapy to manage symptoms and improve quality of life.
    • harvesting of peripheral blood stem cells, prior to autologous stem-cell transplantation
    • to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (Effective 11/13/2015 based on FDA approval)
    • supportive care in the post-transplant setting

Tbo-filgrastim is covered for the following uses:

    • to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
    • in mobilization of hematopoietic progenitor cells in the autologous setting as a single agent, following combination chemotherapy, or in combination with plerixafor when the transplant procedure is a covered benefit
    • used in hematopoietic cell transplant for supportive care in the post-transplant setting
    • anemia in myelodysplastic syndrome; in combination with epoetin
    • for patients who present with acute exposure to myelosuppressive doses of radiation

Utilization:

Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Coding Information:

When filgrastim, filgrastim-sndz or filgrastim-aafi is used for febrile neutropenia, neutropenia of eclampsia or neutropenia associated with HIV disease, both a primary and a secondary diagnosis is required. Please see primary and secondary diagnosis tables located in the "ICD-10 Codes that are Covered" section.

There is a separate diagnosis listing for filgrastim, filgrastim-sndz and filgrastim-aafi when used for all other conditions listed in the "Indications" section. Only a single diagnosis is required.

Only the following ICD-10-CM codes, D61.810, D70.1, T45.1X5A - T45.1X5S, T66.XXXA, T66.XXXD, T66.XXXS, Z41.8, Z48.290, Z51.11, Z51.12, Z51.89, Z52.001, Z52.011, Z52.091, Z76.89, Z91.89, Z94.81 and Z94.84, support medical necessity for pegfilgrastim, pegfilgrastim-jmdb and pegfilgrastim-cbqv.
 
Based on Transmittal 1542, HCPCS code Q5101 must be billed with modifier ZA to identify the manufacturer for biosimilar drugs. Effective for dates of service on or after 01/01/2016, HCPCS code Q5101 submitted without modifier ZA will be returned to the provider. Based on Transmittal 3966, the ZA modifier is no longer required effective 4/1/2018.

Sources of Information:

American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD: 2007.

Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 06/25/2019.

Empire Medicare Services carrier LCD NY [L7515]

FDA label for filgrastim-sndz (Zarxio™). FDA Web site Accessed on 03/16/2015

FDA label for Tbo-filgrastim (Granix™). FDA Web site Accessed 01/08/2014.

FDA label for pegfilgrastim-jmdb, (Fulphila™). FDA Web site. Accessed on 08/24/2018.

FDA label for filgrastim-aafi, (Nivestym™). https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761080s000lbl.pdf. Accessed 08/24/2018.

FDA label for pegfilgrastim-cbqv, (Udenyca™). FDA Website Accessed 12/12/2018.  
  
Lexi-Drugs Web site. http://online.lexi.com. Accessed 06/25/2019.

Micromedex DrugDex®. http://www.thomsonhc.com/home/dispatch. Accessed 06/25/2019.

National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 06/25/2019.

The following sources were added as a result of a reconsideration request received on March 28, 2012:

Aapro MS, Cameron DA, Pettengell R, et al. EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. European Journal of Cancer. 2006;42:2433-2453.

Brusamolino E, Rusconi C, Montalbetti L, et al. Dose-dense R-CHOP-14 supported by pegfilgrastim in patients with diffuse large B-cell lymphomas: a phase II study of feasibility and toxicity. Haematologica. 2006;91:496-502.

Burstein HJ, Parker LM, Keshaviah A, et al. Efficacy of pegfilgrastim and darbepoetin alfa as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy. Journal of Clinical Oncology. 2005;23(33)8340-8347.

Engery A, Doehner H, Ho AD, et al. Pegfilgrastim supports delivery of BEACOPP chemotherapy administered every 14 days. The Journal of Supportive Oncology. 2005;3(2)supplement 1:48-49.

Hecht JR, Pillai M, Gollard R, et al. A randomized, placebo-controlled phase II study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clinical Colorectal Cancer. 2010;9(2):95-101.

Lopez A, de Sevilla AF, Castaigne S, et al. Pegfilgrastim supports delivery of CHOP-R chemotherapy administered every 14 days: a randomized phase II study. The Journal Of Supportive Oncology. 2005;3(2)supplement 1:46-47.

Mey UJM, Maier A, Schmidt-Wolf IGH, et al. Pegfilgrastim as hematopoietic support for dose-dense chemoimmunotherapy with R-CHOP-14 as first line therapy in elderly patients with diffuse large B cell lymphoma. Support Care Cancer. 2007;15:877-884.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™). Myeloid Growth Factors. Version 1.2011. NCCN.org.

Piedbois P, Serin D, Priou F, et al. Dose-dense adjuvant chemotherapy in node-positive breast cancer: docetaxel followed by epirubicin/cyclophosphamide (T/EC), or the reverse sequence (EC/T), every 2 weeks, versus docetaxel, epirubicin and cyclophosphamide (TEC) every 3 weks. AERO B03 randomized phase II study. Anals of Oncology. 2007;18:52-57.

Pirker R, Ulsperger E, Messner J, et al. Achieving full-dose, on-schedule administration of ACE chemotherapy every 14 days for the treatment of patients with extensive small-cell lung cancer. Lung. 2006;184:279-285.

Yang B-B, Hill RL, Hollifield AM, et al. Pegfilgrastim serum concentrations on the twelfth day after dosing are unlikely to stimulate granulopoiesis: a retrospective analysis of six clinical trials in a variety of cancer populations. The Journal Of Supportive Oncology. 2004;2(2):48-49.

Younes A, Fayad L, Romaguera J, Pro B, Goy A, Wang M. Safety and efficacy of once-per-cycle pegfilgrastim in support of ABVD chemotherapy in patients with Hodgkin lymphoma. European Journal of Cancer. 2006;42:2976-2981.


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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Bill Type Code Description
011x Hospital Inpatient (Including Medicare Part A)
013x Hospital Outpatient
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 article, 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 article should be assumed to apply equally to all Revenue Codes.

N/A

CPT/HCPCS Codes

Group 1 Paragraph:

Effective for dates of service on or after 01/01/2016, HCPCS code Q5101 must be billed with modifier ZA. Based on Transmittal 3966, the ZA modifier is no longer required effective 4/1/2018.

Group 1 Codes:

CPT/HCPCS Code Description
J1442 INJECTION, FILGRASTIM (G-CSF), EXCLUDES BIOSIMILARS, 1 MICROGRAM
J1447 INJECTION, TBO-FILGRASTIM, 1 MICROGRAM
J2505 INJECTION, PEGFILGRASTIM, 6 MG
Q5101 INJECTION, FILGRASTIM-SNDZ, BIOSIMILAR, (ZARXIO), 1 MICROGRAM
Q5108 INJECTION, PEGFILGRASTIM-JMDB, BIOSIMILAR, (FULPHILA), 0.5 MG
Q5110 INJECTION, FILGRASTIM-AAFI, BIOSIMILAR, (NIVESTYM), 1 MICROGRAM
Q5111 INJECTION, PEGFILGRASTIM-CBQV, BIOSIMILAR, (UDENYCA), 0.5 MG.

ICD-10 Codes that are Covered

Group 1 Paragraph:

The ICD-10-CM codes listed below support medical necessity for pegfilgrastim, pegfilgrastim-jmdb and pegfilgrastim-cbqv.

Group 1 Codes:

ICD-10 Code Description
D61.810 Antineoplastic chemotherapy induced pancytopenia
D70.1 Agranulocytosis secondary to cancer chemotherapy
T45.1X5A Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S Adverse effect of antineoplastic and immunosuppressive drugs, sequela
T66.XXXA Radiation sickness, unspecified, initial encounter
T66.XXXD Radiation sickness, unspecified, subsequent encounter
T66.XXXS Radiation sickness, unspecified, sequela
Z41.8 Encounter for other procedures for purposes other than remedying health state
Z48.290 Encounter for aftercare following bone marrow transplant
Z51.11 Encounter for antineoplastic chemotherapy
Z51.12 Encounter for antineoplastic immunotherapy
Z51.89 Encounter for other specified aftercare
Z52.001 Unspecified donor, stem cells
Z52.011 Autologous donor, stem cells
Z52.091 Other blood donor, stem cells
Z76.89 Persons encountering health services in other specified circumstances
Z91.89 Other specified personal risk factors, not elsewhere classified
Z94.81 Bone marrow transplant status
Z94.84 Stem cells transplant status

Group 2 Paragraph: 

The ICD-10-CM codes listed below support the medical necessity of filgrastim, filgrastim-sndz and filgrastim-aafi when used for febrile neutropenia, neutropenia of eclampsia or neutropenia associated with HIV disease. Note that claims require both a primary (from Group 2) and a secondary diagnosis (from Group 3).

Primary Diagnosis

Group 2 Codes:

ICD-10 Code Description
D70.3 Neutropenia due to infection
D70.9 Neutropenia, unspecified
D72.818 Other decreased white blood cell count
D72.819 Decreased white blood cell count, unspecified

Group 3 Paragraph: Secondary Diagnosis

Group 3 Codes:

ICD-10 Code Description
B20 Human immunodeficiency virus [HIV] disease
O14.00 Mild to moderate pre-eclampsia, unspecified trimester
O14.02 Mild to moderate pre-eclampsia, second trimester
O14.03 Mild to moderate pre-eclampsia, third trimester
O14.04 Mild to moderate pre-eclampsia, complicating childbirth
O14.05 Mild to moderate pre-eclampsia, complicating the puerperium
O14.12 Severe pre-eclampsia, second trimester
O14.13 Severe pre-eclampsia, third trimester
O14.14 Severe pre-eclampsia complicating childbirth
O14.15 Severe pre-eclampsia, complicating the puerperium
O14.22 HELLP syndrome (HELLP), second trimester
O14.23 HELLP syndrome (HELLP), third trimester
O14.24 HELLP syndrome, complicating childbirth
O14.25 HELLP syndrome, complicating the puerperium
O14.90 Unspecified pre-eclampsia, unspecified trimester
O14.92 Unspecified pre-eclampsia, second trimester
O14.93 Unspecified pre-eclampsia, third trimester
O14.94 Unspecified pre-eclampsia, complicating childbirth
O14.95 Unspecified pre-eclampsia, complicating the puerperium
O15.2 Eclampsia complicating the puerperium
R50.81 Fever presenting with conditions classified elsewhere

Group 4 Paragraph: 

The ICD-10-CM codes listed below support the medical necessity of filgrastim, filgrastim-sndz and filgrastim-aafi for indications not listed above in the Group 2 paragraph.

Group 4 Codes:

ICD-10 Code Description
C88.2 Heavy chain disease
C88.3 Immunoproliferative small intestinal disease
C88.8 Other malignant immunoproliferative diseases
C88.9 Malignant immunoproliferative disease, unspecified
C90.10 Plasma cell leukemia not having achieved remission
C90.11 Plasma cell leukemia in remission
C90.20 Extramedullary plasmacytoma not having achieved remission
C90.21 Extramedullary plasmacytoma in remission
C90.30 Solitary plasmacytoma not having achieved remission
C90.31 Solitary plasmacytoma in remission
C91.00 Acute lymphoblastic leukemia not having achieved remission
C91.01 Acute lymphoblastic leukemia, in remission
C91.02 Acute lymphoblastic leukemia, in relapse
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11 Chronic lymphocytic leukemia of B-cell type in remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
C91.30 Prolymphocytic leukemia of B-cell type not having achieved remission
C91.31 Prolymphocytic leukemia of B-cell type, in remission
C91.32 Prolymphocytic leukemia of B-cell type, in relapse
C91.40 Hairy cell leukemia not having achieved remission
C91.41 Hairy cell leukemia, in remission
C91.42 Hairy cell leukemia, in relapse
C91.50 Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission
C91.51 Adult T-cell lymphoma/leukemia (HTLV-1-associated), in remission
C91.52 Adult T-cell lymphoma/leukemia (HTLV-1-associated), in relapse
C91.60 Prolymphocytic leukemia of T-cell type not having achieved remission
C91.61 Prolymphocytic leukemia of T-cell type, in remission
C91.62 Prolymphocytic leukemia of T-cell type, in relapse
C91.A0 Mature B-cell leukemia Burkitt-type not having achieved remission
C91.A1 Mature B-cell leukemia Burkitt-type, in remission
C91.A2 Mature B-cell leukemia Burkitt-type, in relapse
C91.Z0 Other lymphoid leukemia not having achieved remission
C91.Z1 Other lymphoid leukemia, in remission
C91.Z2 Other lymphoid leukemia, in relapse
C91.90 Lymphoid leukemia, unspecified not having achieved remission
C91.91 Lymphoid leukemia, unspecified, in remission
C91.92 Lymphoid leukemia, unspecified, in relapse
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.01 Acute myeloblastic leukemia, in remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.10 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission
C92.11 Chronic myeloid leukemia, BCR/ABL-positive, in remission
C92.12 Chronic myeloid leukemia, BCR/ABL-positive, in relapse
C92.20 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission
C92.21 Atypical chronic myeloid leukemia, BCR/ABL-negative, in remission
C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse
C92.30 Myeloid sarcoma, not having achieved remission
C92.31 Myeloid sarcoma, in remission
C92.32 Myeloid sarcoma, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.41 Acute promyelocytic leukemia, in remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.51 Acute myelomonocytic leukemia, in remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.61 Acute myeloid leukemia with 11q23-abnormality in remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A1 Acute myeloid leukemia with multilineage dysplasia, in remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C92.Z0 Other myeloid leukemia not having achieved remission
C92.Z1 Other myeloid leukemia, in remission
C92.Z2 Other myeloid leukemia, in relapse
C92.90 Myeloid leukemia, unspecified, not having achieved remission
C92.91 Myeloid leukemia, unspecified in remission
C92.92 Myeloid leukemia, unspecified in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C93.10 Chronic myelomonocytic leukemia not having achieved remission
C94.00 Acute erythroid leukemia, not having achieved remission
C94.02 Acute erythroid leukemia, in relapse
C94.20 Acute megakaryoblastic leukemia not having achieved remission
C94.22 Acute megakaryoblastic leukemia, in relapse
C94.40 Acute panmyelosis with myelofibrosis not having achieved remission
C94.41 Acute panmyelosis with myelofibrosis, in remission
C94.42 Acute panmyelosis with myelofibrosis, in relapse
C94.6 Myelodysplastic disease, not classified
D46.0 Refractory anemia without ring sideroblasts, so stated
D46.1 Refractory anemia with ring sideroblasts
D46.20 Refractory anemia with excess of blasts, unspecified
D46.21 Refractory anemia with excess of blasts 1
D46.22 Refractory anemia with excess of blasts 2
D46.A Refractory cytopenia with multilineage dysplasia
D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts
D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality
D46.4 Refractory anemia, unspecified
D46.Z Other myelodysplastic syndromes
D46.9 Myelodysplastic syndrome, unspecified
D47.1 Chronic myeloproliferative disease
D47.Z9 Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue
D47.9 Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified
D61.1 Drug-induced aplastic anemia
D61.2 Aplastic anemia due to other external agents
D61.3 Idiopathic aplastic anemia
D61.810 Antineoplastic chemotherapy induced pancytopenia
D61.811 Other drug-induced pancytopenia
D61.818 Other pancytopenia
D61.82 Myelophthisis
D61.89 Other specified aplastic anemias and other bone marrow failure syndromes
D70.0 Congenital agranulocytosis
D70.1 Agranulocytosis secondary to cancer chemotherapy
D70.2 Other drug-induced agranulocytosis
D70.4 Cyclic neutropenia
D70.8 Other neutropenia
D70.9 Neutropenia, unspecified
K12.31 Oral mucositis (ulcerative) due to antineoplastic therapy
K12.33 Oral mucositis (ulcerative) due to radiation
T45.1X5A Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S Adverse effect of antineoplastic and immunosuppressive drugs, sequela
T66.XXXA Radiation sickness, unspecified, initial encounter
T66.XXXD Radiation sickness, unspecified, subsequent encounter
T66.XXXS Radiation sickness, unspecified, sequela
Z41.8 Encounter for other procedures for purposes other than remedying health state
Z48.290 Encounter for aftercare following bone marrow transplant
Z51.11 Encounter for antineoplastic chemotherapy
Z51.12 Encounter for antineoplastic immunotherapy
Z51.89 Encounter for other specified aftercare
Z52.001 Unspecified donor, stem cells
Z52.011 Autologous donor, stem cells
Z52.091 Other blood donor, stem cells
Z76.82 Awaiting organ transplant status
Z76.89 Persons encountering health services in other specified circumstances
Z91.89 Other specified personal risk factors, not elsewhere classified
Z94.81 Bone marrow transplant status
Z94.84 Stem cells transplant status

Group 5 Paragraph: The ICD-10-CM codes listed below support medical necessity for Tbo-filgrastim

Group 5 Codes:

ICD-10 Code Description
C93.10 Chronic myelomonocytic leukemia not having achieved remission
D46.0 Refractory anemia without ring sideroblasts, so stated
D46.1 Refractory anemia with ring sideroblasts
D46.20 Refractory anemia with excess of blasts, unspecified
D46.21 Refractory anemia with excess of blasts 1
D46.A Refractory cytopenia with multilineage dysplasia
D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts
D46.4 Refractory anemia, unspecified
D46.Z Other myelodysplastic syndromes
D46.9 Myelodysplastic syndrome, unspecified
D70.1 Agranulocytosis secondary to cancer chemotherapy
D70.3 Neutropenia due to infection
D70.8 Other neutropenia
D70.9 Neutropenia, unspecified
T45.1X5A Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S Adverse effect of antineoplastic and immunosuppressive drugs, sequela
T66.XXXA Radiation sickness, unspecified, initial encounter
T66.XXXD Radiation sickness, unspecified, subsequent encounter
T66.XXXS Radiation sickness, unspecified, sequela
Z41.8 Encounter for other procedures for purposes other than remedying health state
Z48.290 Encounter for aftercare following bone marrow transplant
Z51.11 Encounter for antineoplastic chemotherapy
Z51.12 Encounter for antineoplastic immunotherapy
Z51.89 Encounter for other specified aftercare
Z52.011 Autologous donor, stem cells
Z76.89 Persons encountering health services in other specified circumstances
Z91.89 Other specified personal risk factors, not elsewhere classified
Z94.81 Bone marrow transplant status
Z94.84 Stem cells transplant status

ICD-10 Codes that are Not Covered

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
08/01/2019
R12
Based on compendia review, the following updates have been made. The indications below have been added for filgrastim, filgrastim-sndz and filgrastim-aafi:
  • for patients who present with acute exposure to myelosuppressive doses of radiation
  • hematopoietic cell transplant for
      • mobilization of hematopoietic progenitor cells in combination with plerixafor in the autologous setting for patients with non-Hodgkin lymphoma or multiple myeloma
      • mobilization of donor hematopoietic progenitor cells (preferred) or for granulocyte transfusion in the allogeneic setting
      • supportive care in the post-transplant setting
ICD-10-CM codes T66.XXXA, T66.XXXD and T66.XXXS have been added to Group 4 for filgrastim, filgrastim-sndz and filgrastim-aafi effective for dates of service on or after 08/01/2019.

The following indication has been added for Tbo-filgrastim:
  • for patients who present with acute exposure to myelosuppressive doses of radiation
ICD-10-CM codes T66.XXXA, T66.XXXD and T66.XXXS have been added to Group 5 for Tbo-filgrastim effective for dates of service on or after 08/01/2019.
01/01/2019
R11
Based on the 2019 annual HCPCS update, HCPCS code Q5111 for pegfilgrastim-cbqv, has been added to the “CPT/HCPCS Codes Group 1 Paragraph” section of the article. Pegfilgrastim-cbqv has been added to the Group 1 Paragraph in the “ICD-10 Codes that are Covered” section and throughout the article.
10/01/2018 R10 Based on Transmittal 4134, HCPCs code Q5108 has been added for pegfilgrastim-jmdb effective for dates of service on or after July 12, 2018 and HCPCs code Q5110 has been added for filgrastim-aafi effective for dates of service on or after 10/01/2018. References to pegfilgrastim-jmdb and filgrastim aafi have been added throughout the article.
07/15/2018 R9 ICD-10-CM code Z51.12 has been added to Group 5 for Tbo-filgrastim effective for dates of service on or after 07/15/2018.
04/01/2018 R8 Based on Transmittal 3966 - Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - April 2018 Update, the description for HCPCS code Q5101 has changed and use of the ZA modifier has been discontinued effective 04/01/2018.

ICD-10-CM codes Z48.290 and Z94.81 have been added to the Group 1 codes for pegfilgrastim effective for dates of service on or after 05/03/2018. ICD-10-CM codes C93.00, C93.02, C93.10, C94.00, C94.02, C94.20 and C94.22 have been added to the Group 4 codes for filgrastim effective for dates of service on or after 05/03/2018. An indication for anemia in myelodysplastic syndrome; in combination with epoetin has been added to the “Indications” section for Tbo-filgrastim. ICD-10-CM codes C93.10, D46.0, D46.1, D46.20, D46.21, D46.A, D46.B, D46.4, D46.Z, D46.9, Z48.290 and Z94.81 have been added to the Group 5 codes for Tbo-filgrastim effective for dates of service on or after 05/03/2018.
10/01/2016 R7 Based on the annual ICD-10-CM code update, ICD-10-CM codes O14.04, O14.05, O14.14, O14.15, O14.24, O14.25, O14.94 and O14.95 have been added to the Group 3 Codes. The descriptor for ICD-10-CM code O15.2 was changed.
09/01/2016 R6 The “Indications” for pegfilgrastim have been revised to include:
  • to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (Effective 11/13/2015 based on FDA approval)
  • supportive care in the posttransplant setting
ICD-10-CM codes T66.XXXA, T66.XXXD and T66.XXXS have been added effective for dates of service on or after 11/13/2015 and ICD-10-CM codes Z52.001, Z52.011 and Z52.091 have been added effective for dates of service on or after 09/01/2016. The “Indications” for filgrastim have been revised to include filgrastim-sndz and the separate listing for filgrastim-sndz has been removed.
06/01/2016 R5 The “Indications” for Tbo-filgrastim have been clarified to indicate hematopoietic cell transplant for supportive care in the post-transplant setting. ICD-10-CM code D70.2 has been added to the Group 4 codes for filgrastim and filgrastim-sndz retroactive to 10/01/2015.
06/01/2016 R4 The “Indications” for Tbo-filgrastim have been revised to include:
  • in mobilization of hematopoietic progenitor cells in the autologous setting as a single agent, following combination chemotherapy, or in combination with plerixafor when the transplant procedure is a covered benefit
  • supportive care in the post-transplant setting
ICD-10-CM codes Z52.011 and Z94.84 have been added for Tbo-filgrastim effective for dates of service on or after 06/01/2016. The first paragraph in the "Indications" section of the article has been revised to include Lexi-Drug compendium. Lexi-Drug Web site has been added to the “Sources of Information” section of the article.
 
01/01/2016 R3 Based on the annual HCPCS update for 2016, HCPCS code J1446 has been deleted and replaced with J1447 and the description for J1442 has changed. The “Coding Information” section has been updated to include the following:
Based on Transmittal 1542, HCPCS code Q5101 must be billed with modifier ZA to identify the manufacturer for biosimilar drugs. Effective for dates of service on or after 01/01/2016, HCPCS code Q5101 submitted without modifier ZA will be returned to the provider.

The following information has been added to the Group 1: Paragraph in the “CPT/HCPCS Codes” section:
Effective for dates of service on or after 01/01/2016, HCPCS code Q5101 must be billed with modifier ZA

 
11/01/2015 R2 The article has been revised to add information for filgrastim-sndz throughout the article. HCPCs code Q5101 has been added to the “CPT/HCPCS Codes” section of the article. Filgrastim-sndz has been added to ICD-10-CM code groups 2, 3 and 4. ICD-10-CM code Z76.89 has been added to the ICD-10-CM code groups 1, 4 and 5 effective 10/1/2015. ICD-10-CM code Z76.89 has also been added to the third paragraph for pegfilgrastim in the “Coding Information” section.
10/01/2015 R1 The place of service guidelines for the Part B MAC have been removed. ICD-10-CM codes T45.1X5A, T45.1X5D and T45.1X5S have been added to ICD-10-CM code groups: Group 1:, Group 4: and Group 5:. ICD-10-CM codes T45.1X5A - T45.1X5S have been added to the list of codes that support medical necessity for pegfilgrastim in the "Coding Information" section and ICD-10-CM code D70.2 has been removed. ICD-10-CM code D70.2 has been removed from Group 1: Group 4: and Group 5:. The dosing information has been removed and replaced with the following Utilization guideline: Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Associated Documents

Related Local Coverage Document(s)

Article(s)
A52855 - Drugs and Biologicals, Coding Article

LCD(s)
L33394 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

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Updated on 07/26/2019 with effective dates 08/01/2019 - N/A
Updated on 12/28/2018 with effective dates 01/01/2019 - N/A
Updated on 10/13/2018 with effective dates 10/01/2018 - N/A
Updated on 07/06/2018 with effective dates 07/15/2018 - N/A
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Article for Filgrastim, Pegfilgrastim, Tbo-filgrastim and biosimilars - Related to LCD L33394 (A52408)
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