- Resources
HALAVEN® FAQ
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.
1. What services does the Eisai Assistance Program
provide for HALAVEN®?
The Eisai Assistance Program is able to assist with patient specific support, benefit
verifications, prior authorization guidance, appeals and denials guidance, alternate
funding referrals, patient assistance enrollment, coding support, claims completion,
and submission guidance and payor policy review. Representatives are available from
8 a.m. to 8 p.m. ET Monday through Friday at 1-866-61-EISAI.
Coverage
2. Does Medicare provide coverage for HALAVEN®?
Based on the criteria of coverage for physician-administered drugs under Medicare
Part B, HALAVEN® is eligible for Medicare coverage and payment. Medicare has
not issued a National Coverage Determination (NCD) for HALAVEN®. Local Medicare
Contractors (Fiscal Intermediary, Carrier or Part A/B Medicare Administrative Contractors
(MAC)) may develop and implement local coverage decisions (LCDs) for HALAVEN®.
Some local contractors may publish LCDs or other coverage instruction through articles
and bulletins that relate to HALAVEN®. However, the absence of a published
coverage policy does not mean that there is no coverage for HALAVEN®. For
more information on Medicare coverage of HALAVEN®, contact the Eisai Assistance
Program at 1-866-61-EISAI.
3. Do Private Payors provide coverage for HALAVEN®?
Third-party payors, including HMO plans, managed care organizations, indemnity plans
and others will likely provide coverage for HALAVEN®. However, specific coverage
requirements and restrictions depend on a patient's benefits and will vary based
on plan type and provider site of service. For more information on commercial payor-specific
coverage of HALAVEN®, contact the Eisai Assistance Program at 1-866-61-EISAI.
4. Does Medicaid provide coverage for HALAVEN®?
HALAVEN® is eligible for coverage under most state Medicaid programs. However,
coverage and reimbursement will vary from state to state as each Medicaid program
establishes its own eligibility standards and determines the type, amount, duration,
and scope of services. In addition, state Medicaid programs may apply coverage and
utilization restrictions such as prior authorization. For more information on Medicaid-specific
coverage of HALAVEN®, contact the Eisai Assistance Program at 1-866-61-EISAI.
5. Does HALAVEN® require prior authorization?
Prior authorization (PA) is the process of obtaining approval from a health plan
for a drug before treating the patient. Payors may apply coverage and utilization
restrictions such as prior authorization. Refer to the sample letter of medical
necessity in this guide or the Eisai Assistance Program at 1-866-61-EISAI for assistance
with prior authorizations.
Coding and Billing
6. What HCPCS Code do I use to bill for HALAVEN®?
Depending on the payor and setting of care, the J9179 HCPCS code may be used to
bill for HALAVEN®. Product code preference may vary by plan, we recommend verifying
a health plan's specific billing policies. The Eisai Assistance Program can assist
in determining which code to use, 1-866-61-EISAI.
7. What is the NDC code for HALAVEN®?
The NDC for HALAVEN® is 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): 62856-0389-01. The Eisai
Assistance Program at 1-866-61-EISAI can answer any questions you have regarding
the NDC for HALAVEN®.
8. What is the billing unit for HALAVEN®?
HALAVEN® may be reported on a claim form using the HCPCS code J9179. One billing
unit for this HCPCS code J9179 represents 0.1 mg. Therefore 10 units may be billed
to account for use of one single-dose vial. For assistance, call the Eisai Assistance
Program at 1-866-61-EISAI or 1-866-61-34724 before completing the claim form to
verify the appropriate units to bill for each HALAVEN® vial.
9. How should HALAVEN® be reported on a claim form
for billing?
Per the FDA-approved label for HALAVEN®, it should be dosed at 1.4mg/m2
and each HALAVEN® vial includes 1.0mg/2.0ml. HALAVEN® may be reported using
the HCPCS code J9179 with the appropriate units used according to the dosage. For
example: a patient that received 3 vials of HALAVEN®, the claim form would include
"J9179 HALAVEN®, eribulin mesylate injection 0.1mg, 30 units". For more information
on coding of HALAVEN®, contact the Eisai Assistance Program at 1-866-61-EISAI.
10. If the claim is denied, what am I suppose to do?
How long does the appeal process take?
You can appeal the decision of the payor to deny coverage of HALAVEN®. An
appeal is a request for a payor to reconsider its denial of a procedure or service.
Each payor has its own specific guidelines regarding appeal. The amount of time
it takes a payor to review an appeal can vary. The reason for the denial of the
request or claim should be in the payor's letter of denial or the patient's Explanation
of Benefits (EOB) letter. Please contact the specific payor to receive an estimated
timeframe. The Eisai Assistance Program at 1-866-61-EISAI can assist with the appeal
process.
Reimbursement
11. How will Medicare reimburse HALAVEN® in Physician
Office?
Medicare Part B reimbursement for HALAVEN® in the physician office setting
is based on average sales price (ASP). Medicare sets an allowable payment amount,
updated quarterly, at ASP+6%. Medicare reimbursement is based on the lesser of this
allowable amount or actual charges, as follows: physician offices are reimbursed
for 80% of the allowable amount and the patient or patient's secondary insurer
is responsible for the remaining 20% coinsurance.
12. How will Medicare reimburse HALAVEN® in Hospital
Outpatient department?
Services paid under the Medicare Hospital Outpatient Prospective Payment System
(OPPS) are assigned to an Ambulatory Payment Classification (APC) code. Each APC
is linked to a payment amount that represents the total payment to the hospital.
In addition, separate payments are made for some drugs, biologicals, and devices.
HALAVEN® now has pass-through. With pass-through status, it is eligible for
separate reimbursement by Medicare at Average Sales Price (ASP) plus 6 percent,
adjusted quarterly. Once pass-through status expires, the reimbursement rate for
HALAVEN® may change.
13. How will Private Payors reimburse HALAVEN®?
Reimbursement for HALAVEN® may be based on a percent mark-up of ASP similar to Medicare reimbursement methodologies. Payment may also be based on a percent mark-up or mark-down of AWP or WAC. For the outpatient setting payment may also be based on facility-specific cost-to-charge ratios. For more information on commercial payor-specific coverage of HALAVEN®, contact the Eisai Assistance Program at 1-866-61-EISAI.
14. How will Medicaid reimburse HALAVEN®?
Reimbursement for HALAVEN® may be based on a percent mark-up of ASP similar to Medicare reimbursement methodologies. Payment may also be based on a percent mark-up or mark-down of AWP or WAC. For the outpatient setting payment may also be based on facility-specific cost-to-charge ratios. For more information on Medicaid-specific coverage of HALAVEN®, contact the Eisai Assistance Program at 1-866-61-EISAI
15. How long does it take to obtain reimbursement for
HALAVEN®?
Medicare may typically pay clean claims which have no issues requiring further investigation, within 30 days. If the payor requests additional information the claims processing may take longer. Contacting payors on a regular basis to track the status of claims can ensure more timely reimbursement. The Eisai Assistance Program at 1-866-61-EISAI can assist with claim submission and tracking.
16. Do customers get reimbursed for only one vial?
What if multiple vials are used?
Payors may reimburse for use of multiple vials. In addition, payors may reimburse
providers for the remainder of the contents of the HALAVEN® single dose vial
if it is not administered and eventually wasted. However, physicians are expected
to schedule patients in such a way that they can use drugs most efficiently, in
a clinically appropriate manner. We recommend verifying the drug wastage requirements
of the specific health plan. For more information see the Billing for Wastage section
of this guide or call the Eisai Assistance Program at 1-866-61-EISAI.
17. What action should I take if I believe I have received
inappropriate HALAVEN® reimbursement?
You can appeal the claim. The Eisai Assistance Program can help you with the appeal.
Please have your claim form information available and call the Eisai Assistance
Program at 1-866-61-EISAI or 1-866-61-34724 to complete a claim appeal.
Indication
- HALAVEN® is 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.
Important Safety Information
Neutropenia
- Monitor complete blood 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 longer than 7 days.
- Severe neutropenia (ANC < 500/mm3) lasting more than one week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes > 3 x ULN and bilirubin > 1.5 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia. Two patients died from complications of febrile neutropenia.
Peripheral Neuropathy
- Patients should be monitored closely for signs of peripheral motor and sensory neuropathy.
- Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received HALAVEN®. Delay administration of HALAVEN® until resolution to Grade 2 or less.
- Neuropathy lasting more than one year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation.
Pregnancy Category D
- HALAVEN® is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks.
QT Prolongation
- In an uncontrolled ECG study in 26 patients, QT prolongation was observed on day 8, with no prolongation on day 1. ECG monitoring is recommended for patients with congestive heart failure, bradyarrhythmias, concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics and electrolyte abnormalities.
- Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN® and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
Most Common Adverse Reactions
- Most common adverse reactions (≥25%) reported in patients receiving HALAVEN® were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%).
- The most common serious adverse reactions reported were febrile neutropenia (4%) and neutropenia (2%).
Please see the HALAVEN® full prescribing information.
