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Billing And coding

Here we provide general billing and coding information for HALAVEN® (eribulin mesylate) injection and related services.

Please check with your patient's payer to verify coding or special billing requirements. Correct coding is the responsibility of the provider submitting a claim for the item or service.

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  • ICD-10-CM Diagnosis Codes

    HALAVEN® is indicated for the treatment of patients with metastatic breast cancer (MBC) who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. HALAVEN® is also indicated for the treatment of unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

    Providers should use current ICD-10-CM codes to report a patient's diagnosis on claim submissions. Below is a list of ICD-10-CM diagnosis codes that may be reasonably related to a diagnosis within the product's approved label. Other codes may be appropriate.

    Correct coding is the responsibility of the provider submitting a claim for the item or service. Please see FDA approved indications for HALAVEN® (eribulin mesylate) injection and check with the payer to verify coding or special billing requirements.

    ICD-10-CM DIAGNOSIS CODE

    DESCRIPTION

    C50.011

    Malignant neoplasm of nipple and areola, right female breast

    C50.012

    Malignant neoplasm of nipple and areola, left female breast

    C50.019

    Malignant neoplasm of nipple and areola, unspecified female breast

    C50.111

    Malignant neoplasm of central portion of right female breast

    C50.112

    Malignant neoplasm of central portion of left female breast

    C50.119

    Malignant neoplasm of central portion of unspecified female breast

    C50.211

    Malignant neoplasm of upper-inner quadrant of right female breast

    C50.212

    Malignant neoplasm of upper-inner quadrant of left female breast

    C50.219

    Malignant neoplasm of upper-inner quadrant of unspecified female breast

    C50.311

    Malignant neoplasm of lower-inner quadrant of right female breast

    C50.312

    Malignant neoplasm of lower-inner quadrant of left female breast

    C50.319

    Malignant neoplasm of lower-inner quadrant of unspecified female breast

    C50.411

    Malignant neoplasm of upper-outer quadrant of right female breast

    C50.412

    Malignant neoplasm of upper-outer quadrant of left female breast

    C50.419

    Malignant neoplasm of upper-outer quadrant of unspecified female breast

    C50.511

    Malignant neoplasm of lower-outer quadrant of right female breast

    C50.512

    Malignant neoplasm of lower-outer quadrant of left female breast

    C50.519

    Malignant neoplasm of lower-outer quadrant of unspecified female breast

    C50.611

    Malignant neoplasm of axillary tail of right female breast

    C50.612

    Malignant neoplasm of axillary tail of left female breast

    C50.619

    Malignant neoplasm of axillary tail of unspecified female breast

    C50.811

    Malignant neoplasm of overlapping sites of right female breast

    C50.812

    Malignant neoplasm of overlapping sites of left female breast

    C50.819

    Malignant neoplasm of overlapping sites of unspecified female breast

    C50.911

    Malignant neoplasm of unspecified site of right female breast

    C50.912

    Malignant neoplasm of unspecified site of left female breast

    C50.919

    Malignant neoplasm of unspecified site of unspecified female breast

    C50.021

    Malignant neoplasm of nipple and areola, right male breast

    C50.022

    Malignant neoplasm of nipple and areola, left male breast

    C50.029

    Malignant neoplasm of nipple and areola, unspecified male breast

    C50.121

    Malignant neoplasm of central portion of right male breast

    C50.122

    Malignant neoplasm of central portion of left male breast

    C50.129

    Malignant neoplasm of central portion of unspecified male breast

    C50.221

    Malignant neoplasm of upper-inner quadrant of right male breast

    C50.222

    Malignant neoplasm of upper-inner quadrant of left male breast

    C50.229

    Malignant neoplasm of upper-inner quadrant of unspecified male breast

    C50.321

    Malignant neoplasm of lower-inner quadrant of right male breast

    C50.322

    Malignant neoplasm of lower-inner quadrant of left male breast

    C50.329

    Malignant neoplasm of lower-inner quadrant of unspecified male breast

    C50.421

    Malignant neoplasm of upper-outer quadrant of right male breast

    C50.422

    Malignant neoplasm of upper-outer quadrant of left male breast

    C50.429

    Malignant neoplasm of upper-outer quadrant of unspecified male breast

    C50.521

    Malignant neoplasm of lower-outer quadrant of right male breast

    C50.522

    Malignant neoplasm of lower-outer quadrant of left male breast

    C50.529

    Malignant neoplasm of lower-outer quadrant of unspecified male breast

    C50.621

    Malignant neoplasm of axillary tail of right male breast

    C50.622

    Malignant neoplasm of axillary tail of left male breast

    C50.629

    Malignant neoplasm of axillary tail of unspecified male breast

    C50.821

    Malignant neoplasm of overlapping sites of right male breast

    C50.822

    Malignant neoplasm of overlapping sites of left male breast

    C50.829

    Malignant neoplasm of overlapping sites of unspecified male breast

    C50.921

    Malignant neoplasm of unspecified site of right male breast

    C50.922

    Malignant neoplasm of unspecified site of left male breast

    C50.929

    Malignant neoplasm of unspecified site of unspecified male breast

    C49.1

    Malignant neoplasm of connective and soft tissue of upper limb, including shoulder

    C49.10

    Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder

    C49.11

    Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder

    C49.12

    Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder

    C49.20

    Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip

    C49.21

    Malignant neoplasm of connective and soft tissue of right lower limb, including hip

    C49.22

    Malignant neoplasm of connective and soft tissue of left lower limb, including hip

    C49.3

    Malignant neoplasm of connective and soft tissue of thorax

    C49.4

    Malignant neoplasm of connective and soft tissue of abdomen

    C49.5

    Malignant neoplasm of connective and soft tissue of pelvis

    C49.6

    Malignant neoplasm of connective and soft tissue of trunk, unspecified

    C49.8

    Malignant neoplasm of overlapping sites of connective and soft tissue

    C49.9

    Malignant neoplasm of connective and soft tissue, unspecified

  • CPT Drug Administration Code

    CPT codes are 5-digit numeric codes established by the American Medical Association (AMA) that describe medical procedures and services. HALAVEN® is administered intravenously (IV) over 2-5 minutes. The following CPT code may be appropriate to report HALAVEN® administration services:

    CPT CODE

    DESCRIPTION

    96409

    Chemotherapy administration, Intravenous, push technique, single or initial substance/drug

    Payers may require physicians to report a different drug administration code when billing for HALAVEN®. We recommend verifying a health plan’s coding policies. The Eisai Assistance Program can provide information to patients and healthcare professionals relating to payer-specific policies and can address other questions regarding coding at: 1-866-61-EISAI1-866-61-EISAI or 1-866-613-47241-866-613-4724.

  • HCPCS Level II Code

    HCPCS codes are 5-digit alphanumeric codes that are assigned to drugs by the Centers for Medicare and Medicaid Services (CMS). HALAVEN® (eribulin mesylate) injection has been assigned the following unique HCPCS codes in the "J" series (known as J codes):

    HALAVEN® HCPCS CODE

    DESCRIPTION

    J9179

    Injection, eribulin mesylate, 0.1 mg

    When billing for a drug, payers require physicians to indicate on the claim form the quantity of product administered to the patient expressed in the number of units described by the HCPCS code. Because the HCPCS code for HALAVEN® is expressed as 0.1 mg, the amount of HALAVEN® administered to a patient is expressed in multiples of 0.1 mg on the claim form.

    EXAMPLE NUMBER OF UNITS TO REPORT FOR HALAVEN®

    2 mg

    Report 20 units of J9179

    3 mg

    Report 30 units of J9179

    We recommend verifying an insurer’s coding policies. The Eisai Assistance Program can provide information to patients and healthcare professionals relating to payer-specific policies and can address other questions at: 1-866-61-EISAI1-866-61-EISAI or 1-866-613-47241-866-613-4724.

  • National Drug Codes (NDC)

    The National Drug Code is a unique 10-digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The NDC number identifies the labeler, product, and trade package size. HALAVEN has been assigned the following NDC number:

    HALAVEN® PACKAGE SIZE

    NDC

    Single-dose vial containing 1.0 mg eribulin mesylate /2 ml solution in a 5ml vial - 1 vial in a carton

    62856-389-01

    Some payers require physicians to report 11-digit NDCs when reporting a drug on a claim form. Converting the 10-digit NDC for HALAVEN to an 11-digit NDC requires adding a zero in the product code section (the middle section) of the NDC. Here is one example of how to report using the 11-digit NDC:

    HALAVEN® 10-DIGIT NDC

    HALAVEN® 11-DIGIT NDC

    62856-389-01

    62856-0389-01

Is a patient eligible for savings?

Find out about eligibility for the HALAVEN $0 Co-pay Program.

LEARN MORE

RESOURCES AND DOCUMENTS

Find information that may help patients access HALAVEN.

LEARN MORE

Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. For additional information, customers should consult with their payers for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.

Indication

HALAVEN® is a microtubule inhibitor indicated for the treatment of patients with:

  • Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

  • Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

HALAVEN® Important Safety Information

Warnings and Precautions

Neutropenia: Severe neutropenia (ANC < 500/mm3) lasting > 1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5 % of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.

Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4 %) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN® and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN® in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

Embryo-Fetal Toxicity: HALAVEN® can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN® and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN® and for 3.5 months following the final dose.

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN® and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.

Adverse Reactions

In patients with mBC receiving HALAVEN®, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58 %), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).

In patients with liposarcoma and leiomyosarcoma receiving HALAVEN®, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN® were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN® were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).

Use in Specific Populations

Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN® and for 2 weeks after the final dose.

Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.

For more information about HALAVEN®, please see full Prescribing Information.

This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries. This site is published by Eisai Inc.

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Indication

HALAVEN® is a microtubule inhibitor indicated for the treatment of patients with:

  • Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

  • Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

HALAVEN® Important Safety Information

Warnings and Precautions

Neutropenia: Severe neutropenia (ANC < 500/mm3) lasting > 1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5 % of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.

Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4 %) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN® and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN® in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

Embryo-Fetal Toxicity: HALAVEN® can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN® and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN® and for 3.5 months following the final dose.

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN® and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.

Adverse Reactions

In patients with mBC receiving HALAVEN®, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58 %), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).

In patients with liposarcoma and leiomyosarcoma receiving HALAVEN®, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN® were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN® were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).

Use in Specific Populations

Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN® and for 2 weeks after the final dose.

Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.

For more information about HALAVEN®, please see full Prescribing Information.

This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries. This site is published by Eisai Inc.