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Local Coverage Determination (LCD) for Plerixafor (Mozobil ®) (L30874)
Contractor Information
Contractor Name First Coast Service Options, Inc.
Contractor Number 09102
Contractor Type MAC - Part B
LCD Information
Document Information
LCD ID Number L30874
LCD Title Plerixafor (Mozobil ®)
Contractor's Determination Number J2562
Primary Geographic Jurisdiction Florida
Oversight Region Region IV
AMA CPT/ADA CDT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.
Original Determination Effective Date
For services performed on or after 06/07/2010
Original Determination Ending Date
Revision Effective Date
For services performed on or after 06/07/2010
Revision Ending Date
CMS National Coverage Policy
Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.
Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual System, Pub 100-02, Chapter 15, Section 50
Indications and Limitations of Coverage and/or Medical Necessity
The availability of stem cell growth factors has lead to the treatment of certain types of cancers by performing peripheral blood stem cell transplants (PBSCT). Performing PBSCT allows a patient to be treated with higher doses of drugs such as chemotherapy or with radiation therapy. PBSCT is a process by which blood-forming cells
that have been destroyed by cancer treatment are replaced after the patient has been treated with chemotherapy or radiation therapy. Two types of cancers commonly treated with PBSCT are non-Hodgkin’s lymphoma (NHL)
and multiple myeloma (MM). NHL is a type of cancer that forms in the cells that make up the immune system and is either fast or slow growing. MM is a type of cancer that forms in the plasma cells (white blood cells). In order
to proceed to the process of performing a PBSCT, the stem cells must be collected through a process called apheresis. To increase the number of stem cells released into the blood stream for collection, the patient may be given a drug called a growth factor (colony stimulating factor).
Plerixafor (Mozobil ®) is not a growth factor. It is a reversible inhibitor of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stomal cell-derived factor-1α (SDF-1α). SDF-1α and CXCR4 are recognized to play a role in the trafficking and homing of human hematopoietic stem cells (HSCs) to the marrow compartment.
Indications
Plerixafor (Mozobil ®) is a hematopoietic stem cell mobilizer approved by the Food and Drug Administration (FDA) to be used for the following indication:
• Mozobil ® is indicated to be used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.
Limitations
Uses of Mozobil ® for any other indications other than listed above is considered not medically reasonable and necessary and not covered by Medicare.
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.
999x Not Applicable
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
J2562 INJECTION, PLERIXAFOR, 1 MG
ICD-9 Codes that Support Medical Necessity
200.00 - 200.08 RETICULOSARCOMA UNSPECIFIED SITE - RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.10 - 200.18 LYMPHOSARCOMA UNSPECIFIED SITE - LYMPHOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.20 - 200.28 BURKITT'S TUMOR OR LYMPHOMA UNSPECIFIED SITE - BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.30 - 200.38 MARGINAL ZONE LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - MARGINAL ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.40 - 200.48 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.50 - 200.58 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.60 - 200.68 ANAPLASTIC LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.70 - 200.78 LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.80 - 200.88 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
202.00 - 202.08 NODULAR LYMPHOMA UNSPECIFIED SITE - NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
202.10 - 202.18 MYCOSIS FUNGOIDES UNSPECIFIED SITE - MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES
202.20 - 202.28 SEZARY'S DISEASE UNSPECIFIED SITE - SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES
202.30 - 202.38 MALIGNANT HISTIOCYTOSIS UNSPECIFIED SITE - MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.40 - 202.48 LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE - LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.50 - 202.58 LETTERER-SIWE DISEASE UNSPECIFIED SITE - LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES
202.60 - 202.68 MALIGNANT MAST CELL TUMORS UNSPECIFIED SITE - MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.70 - 202.78 PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
202.80 - 202.88 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE - OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.90 - 202.98 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES
203.1 - 203.2 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MULTIPLE MYELOMA IN REMISSION
Diagnoses that Support Medical Necessity
See ICD-9 codes that support medical necessity
ICD-9 Codes that DO NOT Support Medical Necessity
Any ICD-9-CM code not listed under ICD-9-CM codes that support medical necessity
XX000 Not Applicable
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity N/A
General Information
Documentations Requirements
Medical record documentation maintained by the performing provider must clearly indicate the medical necessity of the services being billed. In addition, documentation that the service was performed must be included in the patient’s medical record. This information is normally found in the history and physical, office/progress notes and/or procedure report.
In addition to the above, the medical record must indicate the G-CSF has been given for four consecutive days prior to the first dose of Mozobil ®. The medical record must also indicate that the Mozobil ® was administered
per the FDA label instructions.
Appendices
Utilization Guidelines Mozobil® is given in conjunction with G-CSF. The only G-SCF that is recognized as medically reasonable and necessary by Medicare MAC J9 is filgrastim (Neupogen), HCPCS codes J1440 and J1441. Medicare MAC J9 has an active local coverage determination for filgrastim and would expect all coverage criteria out lined in that LCD to be met, including ICD-9-CM coding. In addition, Medicare MAC J9 would not expect to see any chemotherapy drugs being billed on the same day as Neupogen when the Neupogen is being given for this course of therapy with Mozobil®.
Dosage and Administration
Treatment with Mozobil® should begin after the patient has received G-CSF once daily for four days. Administer Mozobil® approximately 11 hours prior to the initiation of apheresis for up to four consecutive days.
The recommended dosage of Mozobil® is 0.24mg/kg body weight by subcutaneous injection. Use the patient’s actual body weight to calculate the volume of Mozobil® to be administered. Doses should not exceed
40mg/day. Administer daily morning doses of G-CSF 10 micrograms/kg for four consecutive days prior to the first evening dose of Mozobil® and on each day prior to apheresis.
For renal impairment: if the creatinine clearance is < or equal to 50 mL/min, the dose should be decreased by 1/3 to 0.16mg/kg.
Sources of Information and Basis for Decision
DiPersio, J., et al (2009). Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood, 113 (23) 5720-5726.
Mozobil® FDA label (2008). Genzyme Corporation. Retrieved from www.fda.gov
Mozobil® patient and caregiver education booklet. Genzyme Corporation. Retrieved from www.mozobil.com
Mozobil® product monograph 2009. Genzyme Corporation. Retrieved from www.mozobil.com National Cancer Institute What you need to know about Multiple Myeloma. Retrieved from
www.cancer.gov/cancertopics/wyntk/myeloma.
National Cancer Institute What you need to know about non-Hodgkin’s lymphoma. Retrieved from www.cancer.gov/cancertopics/wyntk/non-hodgkin-lymphoma
National Cancer Institute fact sheet on bone marrow transplantation and peripheral blood stem cell transplantation. Retrieved from www.cancer.gov/cancertopics/factsheet/Therapy/bonemarrow-transplant.
Plerixafor. Clinical Pharmacology (2009). Retrieved from www.clinicalpharmacology.com
Tricot, G., Cottler-Fox, M.H., and Calandra, G. (2009). Safety and efficacy assessment of plerixafor in patients with multiple myeloma proven or predicted to be poor mobilizers, including assessment of tumor cell mobilization.
Bone Marrow Transplantation 1-6. Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.
Florida Contractor Advisory Committee meeting February 13, 2010
Puerto Rico/U.S. Virgin Islands Contractor Advisory Committee meeting February 25, 2010
Start Date of Comment Period 02/04/2010
End Date of Comment Period 03/20/2010
Start Date of Notice Period 04/23/2010
Revision History Number Original
Revision History Explanation Revision Number:Original Start Date of Comment Period:02/04/2010
Start Date of Notice Period:04/23/2010 Original Effective Date:06/07/2010
LCR B2010 - 039
April 2010 Update
Reason for Change
Related Documents
This LCD has no Related Documents.
LCD Attachments
Coding Guidelines
Comment Summary (02/04/10 - 03/20/10)
All Versions
Updated on 06/07/2010 with effective dates 06/07/2010 - N/A Updated on 04/07/2010 with effective dates 06/07/2010 - N/A
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