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Billing & Coding

Correct coding is the responsibility of the provider submitting a claim for the item or service. Here we provide general billing and coding information for HALAVEN® (eribulin mesylate) injection. Please check with the payor to verify coding or special billing requirements.

International Classification of Diseases, Tenth Revision (ICD-10) 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 payor to verify coding or special billing requirements.

ICD-10-CM Diagnosis Code1

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

 

 

1. Centers for Medicare and Medicaid Services. ICD-10-CM Complete Code Set 2016. Copyright AAPC 2016. Available at http://www.cms.gov/Medicare/Coding/ICD10/index.html?redirect=/ICD10. Accessed February 29, 2016.

Current Procedural Terminology (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

Payors 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 payor-specific policies and can address other questions regarding coding at: 1-866-61-EISAI or 1-866-613-4724.

Healthcare Common Procedure Coding System (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, payors 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 payor-specific policies and can address other questions at: 1-866-61-EISAI or 1-866-613-4724.

National Drug Codes

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. The HALAVEN® is listed below.

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 payors 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 the use of a leading zero in the product code section of the NDC (i.e., the middle section):

10-Digit NDC Example ®

11-Digit NDC Example with Leading Zero

AAAAA-BBB-CC

AAAAA-0BBB-CC

HALAVEN® 10-Digit NDC

HALAVEN® 11-Digit NDC with Leading Zero

62856-389-01

62856-0389-01

Revenue codes capture facility cost data by department, which the facility uses for cost reporting purposes. Some payors request that providers report revenue codes on claim forms. Hospital outpatient departments may typically report revenue code 0636 for HALAVEN®1:

Revenue Code

Description

0250

General pharmacy

0636

Drugs requiring detailed coding

1. Hospital Outpatient PPS. Revenue codes. Revenue Code to Cost Center Crosswalk. Information available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Annual-Policy-Files-Items/2015-Annual-Policy-Files.html. Accessed March 3, 2016.

Average Sales Price (ASP) rates are recalculated and released on a quarterly basis by CMS but can be updated more frequently. Please visit the CMS website below for the most up to date information.

HALAVEN® is currently separately reimbursed in the skilled nursing facility (SNF) setting. HALAVEN® is excluded from SNF consolidated billing for claims submitted to Fiscal Intermediaries/A/B MACS for payment. This is effective for claims with dates of service as of January 1, 2014.1

For additional information and assistance with HALAVEN®, please contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-61-34724, Monday through Friday from 8:00 am - 8:00 pm ET.

Medicare Reimbursement Rate – Physician Office2

Reimbursement Rate – Hospital Outpatient3 Rates are subject to change.

For additional information and assistance with HALAVEN®, please contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-61-34724, Monday through Friday from 8:00 am - 8:00 pm ET.

References

1.Centers for Medicare and Medicaid Services Website, Overview on Skilled Nursing Facility Consolidated Billing, 2016 Carrier A/B MAC Update. https://www.cms.gov/Medicare/Billing/SNFConsolidatedBilling/2016-Part-B-MAC-Update.html . Accessed March 3, 2016.

2. Centers for Medicare & Medicaid Services Website, Medicare, Medicare Part B Drug Pricing Files. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html . Accessed on March 3, 2016.

3. Centers for Medicare & Medicaid Services Website, Medicare, Hospital Outpatient PPS. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates.html . Accessed on March 3, 2016.

Payors may reimburse providers for the remainder of the contents of the HALAVEN® single dose vial if it is not administered and it must be discarded. However, payors expect physicians to schedule patients in such a way that they can use drugs most efficiently, in a clinically appropriate manner. Drug wastage may be documented in the patient’s medical record with the date, time, amount wasted, and reason for wastage. Each payor may have different policies regarding drug wastage and may require physicians to include the amount of product administered and the amount discarded when line item billing for HALAVEN®. We recommend verifying the drug wastage requirements of the specific health plan. Finally, some payors request that physicians identify any discarded product by appending the JW modifier to the claim.

Do Your Patients Need Financial Assistance?

Programs run by Eisai and Assistance Foundations are available to manage out-of-pocket costs

Who is an Appropriate Patient for HALAVEN®?

Choose HALAVEN® when your goal is extending life in third line

Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors 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. 

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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 m3) 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.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.FDA.gov/medwatch or call 1-800-FDA-1088.

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.

HALAVEN® is a registered trademark used by Eisai under license from Eisai R & D Management Co., Ltd.
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