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Sample CMS-1450 (UB-04)
Claim Form
This document is an example of a typical claim for a patient who receives VELCADE® (bortezomib) for an FDA-approved
indication by subcutaneous injection or IV push technique, where the facility supplies and administers the product. This is
not intended to be applicable to every billing scenario and/or payer.
VELCADE is indicated for the treatment of patients with multiple myeloma.
VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.
VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or
mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration.
CMS-1450 (UB-04) Claim Form completion for VELCADE for
hospital outpatient services
Box 42: REVENUE CODE
Box 46: UNITS
Drug:
Report the appropriate unit of service. Because VELCADE is billed “per 0.1 mg”, billing
Medicare for one 3.5 mg vial would generally require indicating 35 units.* Medicaid and
other payers may have different requirements (e.g., some Medicaid programs limit billing
units to amount administered). This should be confirmed with the appropriate payer.
Medicare encourages Revenue Code 0636 (drugs requiring
detailed coding), while other payers may require the use
of different Revenue Codes. This information should be
confirmed by payer.
Procedure:
Medicare and most other payers will require a Revenue
Code for each procedure executed. Revenue Code 0331 is
listed to indicate “chemotherapy administration—injected.”
*Medicare will not permit billing for any residual product in a vial in excess of 35 units.
Additionally, Medicare will not permit billing for any units in a vial that have been billed
separately (as either administered or as discarded). Some Medicare MACs require use
of a “JW” modifier to indicate discarded product on a separate line item.
Box 43: DESCRIPTION
Box 44: PRODUCT AND PROCEDURE CODING
Product:
Product Code:
Provide the definition associated with J9041 as
indicated in box 43 [VELCADE for Injection per
0.1 mg].
Procedure:
Based on the appropriate Revenue Code,
distinctive definitions will result. For instance,
a common Revenue Code will be 0331, which
would then require a description of “chemotherapy
administration—injected.”
Use HCPCS code J9041: VELCADE for Injection per
0.1 mg to indicate VELCADE on the claim form to
correspond with Revenue Code 0636, indicating drugs
requiring detailed coding.
Procedure Code:
Enter the CPT code that represents the administration
procedure performed:
96401 (chemotherapy administration, subcutaneous or
intramuscular; non-hormonal anti-neoplastic)
or
96409 (chemotherapy administration; intravenous, push
technique, single or initial substance/drug)
Box 69: DIAGNOSIS CODE
Enter the appropriate ICD-9-CM diagnosis code(s) that
reflect(s) the histology of the disease with which the
patient is diagnosed.
Diagnosis codes for VELCADE use include:
203.00–203.02 Multiple myeloma
200.40–200.48 Relapsed mantle cell lymphoma
Box 80: REMARKS
To support claims review and payment, include the
NDC code for VELCADE (the NDC# for VELCADE is
63020-0049-01), quantity of the drug administered,
and date the drug was administered.
Please see Important Safety Information for VELCADE on page 2.
This information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Laws, regulation and policies concerning reimbursement are complex and are
updated frequently. Individual coding decisions should be based upon diagnosis and treatment of individual patients. While we have made an effort to be current as of the issue date of this document,
the information may not be as current or comprehensive when you view it. Please consult with your legal counsel or Case Manager for any reimbursement or billing questions. For more information
please call the VELCADE Reimbursement Assistance Program at 1-866-VELCADE (835-2233), option 2.
VELCADE Reimbursement Assistance Program (VRAP) 1-866-VELCADE (835-2233), OPTION 2 • www.velcadeHCP.com
Page 1
Indications and Important Safety Information
for VELCADE® (bortezomib)
INDICATIONS: VELCADE (bortezomib) is indicated for the
treatment of patients with multiple myeloma. VELCADE is indicated for
the treatment of patients with mantle cell lymphoma who have received at least
1 prior therapy.
CONTRAINDICATIONS: VELCADE (bortezomib) is contraindicated in patients with
hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including
anaphylactic reactions. VELCADE is contraindicated for intrathecal administration.
WARNINGS AND PRECAUTIONS: VELCADE is for subcutaneous or IV administration only. Because each
route of administration has a different reconstituted concentration, caution should be used when calculating the
volume to be administered.
▼ Peripheral neuropathy, including severe cases, may occur. Patients should be monitored for symptoms and
peripheral neuropathy (including ≥Grade 3). Starting with VELCADE subcutaneously may be considered for patients who
either have preexisting or are at high risk for peripheral neuropathy.
▼ Hypotension: Caution should be used when treating patients receiving antihypertensives, those with a history of syncope,
and those who are dehydrated.
▼ Cardiac toxicity, including acute development or exacerbation of congestive heart failure and new onset of decreased left
ventricular ejection fraction, has occurred. Isolated cases of QT-interval prolongation have been reported. Patients with risk
factors for, or existing, heart disease should be closely monitored.
▼ Pulmonary toxicity:
disease, has been reported. In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE
until a prompt and comprehensive diagnostic evaluation is conducted.
▼ Posterior reversible encephalopathy syndrome has occurred. Consider MRI imaging for onset of visual or neurological
symptoms; discontinue VELCADE if suspected.
▼ Gastrointestinal toxicity, including nausea, diarrhea, constipation, and vomiting, has occurred and may require use of
▼ Thrombocytopenia/Neutropenia:
monitored frequently during treatment. There have been reports of gastrointestinal and intracerebral hemorrhage. Transfusions
may be considered.
▼ Tumor lysis syndrome: Closely monitor patients with high tumor burden and take appropriate precautions.
▼ Hepatic toxicity: Monitor hepatic enzymes during treatment. Upon occurrence, interrupt therapy with VELCADE to
assess reversibility.
▼ Embryo-fetal risk: Women should avoid breast-feeding or becoming pregnant while on VELCADE.
▼ Patients with diabetes may require close monitoring and adjustment of the antidiabetic medications.
DRUG INTERACTIONS: Closely monitor patients receiving VELCADE in combination with strong CYP3A4 inhibitors. Avoid
concomitant use of strong CYP3A4 inducers.
ADVERSE REACTIONS
▼ Previously untreated multiple myeloma (MM): In the phase 3 study of VELCADE administered intravenously with melphalan
and prednisone (MP) vs MP alone, the most commonly reported adverse reactions (ARs) were thrombocytopenia (48% vs 42%),
neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia
(34% vs <1%), anemia (32% vs 46%), and leukopenia (32% vs 28%).
▼ Relapsed MM and mantle cell lymphoma: In the integrated analysis of 1163 patients in phase 2 and 3 studies of VELCADE
administered intravenously, the most commonly reported ARs were nausea (49%), diarrhea NOS (46%), fatigue (41%), peripheral
neuropathy NEC (38%), and thrombocytopenia (32%). A total of 26% of patients experienced serious ARs. The most commonly
reported serious ARs included diarrhea, vomiting, and pyrexia (each 3%); nausea, dehydration, and thrombocytopenia (each 2%);
and pneumonia, dyspnea, peripheral neuropathies NEC, and herpes zoster (each 1%).
▼ Relapsed MM subcutaneous vs IV: In the phase 3 study of VELCADE administered subcutaneously vs intravenously in
relapsed MM, safety data were similar between the two treatment groups. The most commonly reported ARs in the subcutaneous
vs IV treatment groups were peripheral neuropathy (37% vs 50%) and thrombocytopenia (30% vs 34%). The incidence of serious
ARs was similar in the subcutaneous treatment group (20%) and the IV treatment group (19%). The most commonly reported
serious ARs were pneumonia and pyrexia (each 2%) in the subcutaneous treatment group and pneumonia, diarrhea, and
peripheral sensory neuropathy (each 3%) in the IV treatment group.
Please see accompanying full Prescribing Information, also available at VELCADEHCP.com.
VELCADE, MILLENNIUM and
are registered trademarks of Millennium Pharmaceuticals, Inc.
Other trademarks are property of their respective owners.
Millennium Pharmaceuticals, Inc., Cambridge, MA 02139
Copyright © 2012, Millennium Pharmaceuticals, Inc.
V-12-031311/12
All rights reserved.
Printed in USA
Please see full Prescribing Information at
velcade.com/Files/PDFs/VELCADE_PRESCRIBING_INFORMATION.pdf