L28787

 

BORTEZOMIB (VELCADE®)

 

04/12/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Bortezomib is FDA approved for injection for the following indications:

• Treatment of patient with multiple myeloma.

• Treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

Bortezomib is covered for its FDA approved indications, as well as for the following off-labeled indications:

• Treatment of relapsed or refractory B-Cell Non-Hodgkin’s lymphoma specifically; follicular lymphoma.

• Induction therapy for multiple myeloma patients in combination with one or more drugs (NCCN, Multiple Myeloma, V.1.2007).

 

Route of Administration

• Per the National Comprehensive Cancer Network (NCCN) Drugs and Biologicals Compendia the OFF LABEL use of bortezomib for subcutaneous administration (SQ) is indicated for multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.

o Therefore, both IV and SQ administration are allowed for this indication.

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.

 

13x Hospital Outpatient

21x Skilled Nursing - Inpatient (Including Medicare Part A)

23x Skilled Nursing - Outpatient

85x 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.

 

 

0636 Pharmacy - Drugs Requiring Detailed Coding

 

CPT/HCPCS Codes

 

J9041 INJECTION, BORTEZOMIB, 0.1 MG

 

ICD-9 Codes that Support Medical Necessity

 

200.40 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.41 MANTLE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

200.42 MANTLE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

200.43 MANTLE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

200.44 MANTLE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.45 MANTLE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.46 MANTLE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

200.47 MANTLE CELL LYMPHOMA, SPLEEN

200.48 MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

202.00 NODULAR LYMPHOMA UNSPECIFIED SITE

202.01 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.02 NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES

202.03 NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.04 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.05 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.06 NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES

202.07 NODULAR LYMPHOMA INVOLVING SPLEEN

202.08 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

202.70 PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

202.71 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

202.72 PERIPHERAL T CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

202.73 PERIPHERAL T CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

202.74 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

202.75 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.76 PERIPHERAL T CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

202.77 PERIPHERAL T CELL LYMPHOMA, SPLEEN

202.78 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

202.80 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE

202.81 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.82 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRATHORACIC LYMPH NODES

202.83 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.84 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.85 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.86 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRAPELVIC LYMPH NODES

202.87 OTHER MALIGNANT LYMPHOMAS INVOLVING SPLEEN

202.88 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES

203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

203.02 MULTIPLE MYELOMA, IN RELAPSE

203.10 PLASMA CELL LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

203.12 PLASMA CELL LEUKEMIA, IN RELAPSE

203.80 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

203.82 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE

238.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS

 

 

Documentation Requirements

• Documentation in the medical record must support that bortezomib is administered for an indication specified in this LCD and all applicable coverage criteria must be clearly documented.

• When a portion of the drug is discarded, the medical record must clearly show the amount administered and the amount wasted.

• If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.

o The physician must state the clinical indications/medical need for using the chemotherapy drug in the order.

• Documentation must be available to Medicare upon request.

• The dose and frequency of administration should be consistent with the FDA product information.

o More than one 3.5 mg single dose vial would not be expected to be billed for each date of service.

o Based on the J9041 code descriptor, 0.1 mg is equal to one billed service.

o Therefore, up to 35 billed services are allowed.

Treatment Logic:

• Bortezomib (Velcade®) is an antineoplastic agent which inhibits the activity of the 26S proteasome.

• It exhibits cytotoxicity to various malignant cells, including myeloma and lymphoma cells.

• Bortezomib is given by intravenous injection (IV).

 

Sources of Information and Basis for Decision

 

Compendia-Based Drug Bulletin, Feb. 2008 Update. The Association of Community Cancer Centers. Available online @ http://www.accc-cancer.org.

 

FCSO LCD 29087, Bortezomib (Velcade®), 04/12/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Fisher, R. I., Wilmot, J. P. (2005). Mantle Cell Lymphoma: At Last, Some Hope for Successful Innovative Treatment Strategies. Journal Clinical Oncology, 23(4): 657-658.

 

Food and Drug Administration (FDA) approval letter NDA 21-602/S-015 and approval label, June 20, 2008.

 

Goy, A., Hagemeister, F., McLaughlin, P., Pro, B., Romaguera, J. E., & Younes, A. (2005). Phase II Study of Proteosome Inhibitor Bortezomib in Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma. Journal of Clinical Oncology, 23 (4): 667-675.

 

Moreau, P., Pylypenko, H., Grosicki,S., Karamanesht, L., Leleu, X., Grishunina, M., Rehtman, G., Maslink, Z., Robak, T., Shubina, A., Arnulf, B., Kropff, M., Cavet, J., Esseeltine, D., Feng, H., Girgis, S., Van De Velde, H., Deraedt, W., Harousseau, J., et al. (2011) Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomized, phase 3, non-inferiority study, The Lancet Oncology, 12, (5): 431- 440.

 

National Comprehensive Cancer Network, Inc. (2006). Multiple Myeloma. NCCN Clinical Practice Guidelines In Oncology – V.1.2007.

 

NCCN Drugs & Biologicals Compendium. (2011) website for Borezomib (Velcade). National Comprehensive Cancer Network. Retrieved 12/15/11 from http://www.nccn.org/professionals/drug_compendium/mainpage.aspx

 

O’Connor, O.A., MacGregor-Cortelli, B., Moskowitz, C., Muzzy, J., Stubblefield, M. & Wright, J. (2005). Phase II Clinical Experience With the Novel Proteosome Inhibitor Bortezomib in Patients With Indolent Non-Hodgkin’s Lymphoma and Mantle Cell Lymphoma. Journal of Clinical Oncology, 23 (4): 676-684.

 

 

AMA CPT 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.

 

© Automated Clinical Guidelines, LLC 2012-2013

 

CMS LCD BORTEZOMIB (VELCADE®)