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Coverage Policies

Please select the appropriate setting of care to ensure that you obtain the appropriate coverage information.

Physician-administered drugs are generally covered under Medicare Part B if (1) they are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice; (2) they are not usually self-administered; and (3) they meet the requirements for coverage of items as incident to a physician's service. The general requirements for coverage under the "incident to" provision are that the drug be of a form that is not usually self-administered and that the drug be furnished and administered by a physician.1 Medicare has not issued a National Coverage Determination (NCD) for ALOXI® (palonosetron HCI injection). Local Medicare contractors (Part A/B Medicare Administrative Contractor [MAC]) may make coverage decisions for ALOXI®. Some local contractors have published Local Coverage Determinations (LCDs) and other coverage instruction through articles and bulletins that relate to ALOXI®. However, the absence of a published coverage policy does not mean that there is no coverage for ALOXI®.

For more information on Medicare coverage for ALOXI®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-613-4724.  

Payor Reimbursement

Medicare Part B reimbursement for ALOXI® in the physician office setting is based on Average Sales Price (ASP). Medicare sets an allowable payment amount, updated quarterly, at ASP plus 6%, adjusted quarterly, however due to recent legislation, Medicare provider payment has been cut under sequestration to ASP plus 4.3%, and may be subject to further change.1 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.

Administration Services

Medicare reimbursement for ALOXI® drug administration services provided in the physician office setting is based on the national fee schedule that is adjusted for geographic variations and updated annually. Medicare reimbursement is based on the lesser of the adjusted fee schedule amount or actual charges, as follows: physicians are reimbursed for 80% of the allowable amount and the patient or patient's secondary insurer is responsible for the remaining 20% coinsurance.

References:
1. Centers for Medicare & Medicaid Services Website, Medicare Provider FFS e-News. Accessed on October 1, 2014 at this address: http://www.cms.gov/Outreach-and-Education/Outreach/FFSProvPartProg/Downloads/2013-03-08-standalone.pdf

ALOXI® (palonosetron HCI injection) 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. Reimbursement rates for services will also vary from state to state. Some Medicaid programs may cover ALOXI® as a medical benefit, pharmacy benefit, or both. In addition, state Medicaid programs may apply coverage and utilization restrictions such as prior authorization or step therapy.

For more information on Medicaid-specific coverage for ALOXI®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Medicaid reimbursement for ALOXI® administered in the physician office setting varies by state Medicaid program. Some Medicaid programs may base reimbursement on a % markup or markdown of ASP. Others may base reimbursement on a % markup or markdown of Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC). Drug reimbursement rates may be updated by state Medicaid programs on a monthly, quarterly, or yearly basis.

Administration Services

Medicaid reimbursement for ALOXI® drug administration services provided in the physician office setting varies by state Medicaid program. Many states base reimbursement on a statewide fee schedule that may be updated on a quarterly or annual basis.

Most third-party payors, including health maintenance organization (HMO) plans, managed care organizations, indemnity plans and others provide coverage for ALOXI®(palonosetron HCI injection). However, specific coverage requirements and restrictions depend on a patient’s benefits and will vary based on plan type and provider site of service. Some payors have established formal published policies, but the lack of a published policy from a particular payor does not mean that ALOXI® is not covered by that payor. Some commercial insurers may apply coverage and utilization restrictions such as prior authorization or step therapy..

For more information on commercial payor-specific coverage for ALOXI®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Commercial payor reimbursement for ALOXI® may be based on a % markup of ASP similar to Medicare reimbursement methodologies. Payment may also be based on a % markup or markdown of Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC).

Administration Services

Commercial payor reimbursement for physician-related ALOXI® drug administration services may be based on a common fee schedule similar to the Medicare reimbursement methodology for physician services or other contracted rates.

Physician-administered drugs are generally covered under Medicare Part B if (1) they are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice; (2) they are not usually self-administered; and (3) they meet the requirements for coverage of items as incident to a physician’s service. The general requirements for coverage under the “incident to” provision are that the drug be of a form that is not usually self-administered and that the drug be furnished and administered by a physician.1 Medicare has not issued a National Coverage Determination (NCD) for ALOXI® (palonosetron HCI injection). Local Medicare contractors (Part A/B Medicare Administrative Contractors [MAC]) may make coverage decisions for ALOXI®. Some local contractors have published Local Coverage Determinations (LCDs) and other coverage instruction through articles and bulletins that relate to ALOXI®. However, the absence of a published coverage policy does not mean that there is no coverage for ALOXI®.

For more information on Medicare coverage for ALOXI®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

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. ALOXI® is separately reimbursed by Medicare under the APC system at ASP plus 6 % adjusted quarterly; however due to recent legislation, Medicare provider payment has been cut under sequestration to ASP plus 4.3%.2

Administration Services

Drug administration Current Procedural Terminology (CPT) codes are assigned to APCs according to their clinical and resource requirements. Several drug administration codes may map to a single APC. APCs for drug administration services are updated yearly by CMS. Drug administration CPT codes may not be paid separately when performed in conjunction with certain surgical procedures.

References:
1. See the Medicare Benefits Policy Manual, Chapter 15, section 50 for further information.

2. See Federal Register. Vol. 79, No. 217, Part II, Department of Health and Human Services, 42 CFR Parts 411, 412, 416 et al. dated November 10, 2014. Accessed on September 11, 2015.

ALOXI® (palonosetron HCI injection) 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. Reimbursement rates for services will also vary from state to state. Some Medicaid programs may cover ALOXI® as a medical benefit, pharmacy benefit, or both. In addition, state Medicaid programs may apply coverage and utilization restrictions such as prior authorization or step therapy.

For more information on Medicaid-specific coverage for ALOXI®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Reimbursement for ALOXI® administered in a hospital outpatient setting varies by state Medicaid program. For instance, payment may be based on a percentage of Average Sales Price (ASP), Average Wholesale Price (AWP), Wholesale Acquisition Cost (WAC), or facility-specific cost-to-charge ratios.

Administration Services

Medicaid reimbursement for ALOXI® drug administration services in the hospital outpatient setting varies by state Medicaid program. For instance, payment rates may be based on a fee schedule, contracted rates, cost-to-charge ratios, or facility-specific per diem methodologies.

Most third-party payors, including health maintenance organization (HMO) plans, managed care organizations, indemnity plans and others provide coverage for ALOXI® (palonosetron HCI injection). However, specific coverage requirements and restrictions depend on a patient’s benefits and will vary based on plan type and provider site of service. Some payors have established formal published policies, but the lack of a published policy from a particular payor does not mean that ALOXI® is not covered by that payor. Some commercial insurers may apply coverage and utilization restrictions such as prior authorization or step therapy.

For more information on commercial payor-specific coverage for ALOXI®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Reimbursement for ALOXI® may be based on a % markup of Average Sales Price (ASP) similar to Medicare reimbursement methodologies. Payment may also be based on a % markup or markdown of Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC) or facility-specific cost-to-charge ratios.

Administration Services

Reimbursement for ALOXI® drug administration services provided in the hospital outpatient setting may be based on a common fee schedule similar to the Medicare reimbursement methodology for physician services, facility-specific cost-to-charge ratios, per diem methodologies or other contracted rates.

Physician-administered drugs are generally covered under Medicare Part B if (1) they are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice; (2) they are not usually self-administered; and (3) they meet the requirements for coverage of items as incident to a physician’s service. The general requirements for coverage under the “incident to” provision are that the drug be of a form that is not usually self-administered and that the drug be furnished and administered by a physician.1 Medicare has not issued a National Coverage Determination (NCD) for ALOXI® (palonosetron HCI injection). Local Medicare contractors (Fiscal Intermediary [FI], Carrier or Part A/B Medicare Administrative Contractor [MAC]) may make coverage decisions for ALOXI®. Some local contractors have published Local Coverage Determinations (LCDs) and other coverage instruction through articles and bulletins that relate to ALOXI®. However, the absence of a published coverage policy does not mean that there is no coverage for ALOXI®.

For more information on Medicare coverage for ALOXI®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

As of January 2008, Medicare has been paying Ambulatory Surgery Center (ASCs) using a payment system based on the hospital OPPS. Drugs that qualify for pass-through payment under the OPPS system and are provided integral to a covered surgical procedure are paid in exactly the same manner as under OPPS. When administered in ASCs and when provided integral to a covered surgical procedure, ALOXI® is reimbursed by Medicare at Average Sales Price (ASP) plus 4%, adjusted quarterly.

Administration Services

Reimbursement for ALOXI® drug administration services provided in the hospital outpatient setting may be based on a common fee schedule similar to the Medicare reimbursement methodology for physician services, facility-specific cost-to-charge ratios, per diem methodologies or other contracted rates.

1. See the Medicare Benefits Policy Manual, Chapter 15, section 50 for further information.

ALOXI® (palonosetron HCI injection) 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. Reimbursement rates for services will also vary from state to state. Some Medicaid programs may cover ALOXI® as a medical benefit, pharmacy benefit, or both. In addition, state Medicaid programs may apply coverage and utilization restrictions such as prior authorization or step therapy.

For more information on Medicaid-specific coverage for ALOXI®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Reimbursement for ALOXI® administered in an ambulatory surgical center setting varies by state Medicaid program. For instance, payment may be based on a percentage of Average Sales Price (ASP), Average Wholesale Price (AWP), Wholesale Acquisition Cost (WAC), or facility-specific cost-to-charge ratios.

Administration Services

Medicaid reimbursement for ALOXI® drug administration services in the ambulatory surgical center setting varies by state Medicaid program. For instance, payment rates may be based on a fee schedule, contracted rates, cost-to-charge ratios, or facility-specific per diem methodologies.

Most third-party payors, including health maintenance organization (HMO) plans, managed care organizations, indemnity plans and others provide coverage for ALOXI® (palonosetron HCI injection). However, specific coverage requirements and restrictions depend on a patient’s benefits and will vary based on plan type and provider site of service. Some payors have established formal published policies, but the lack of a published policy from a particular payor does not mean that ALOXI® is not covered by that payor. Some commercial insurers may apply coverage and utilization restrictions such as prior authorization or step therapy.

For more information on commercial payor-specific coverage for ALOXI®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Reimbursement for ALOXI® may be based on a % markup of Average Sales Price (ASP) similar to Medicare reimbursement methodologies. Payment may also be based on a % markup or markdown of Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC) or facility-specific cost-to-charge ratios.

Administration Services

Reimbursement for ALOXI® drug administration services provided in the ambulatory surgical center setting may be based on a common fee schedule similar to the Medicare reimbursement methodology for physician services, facility-specific cost-to-charge ratios, per diem methodologies or other contracted rates.

Need Help with HCPS Codes?

HCPCS codes that have been assigned to identify ALOXI® for billing and coding purposes.

Powerful Prevention of Chemotherapy-Induced Nausea and Vomiting

ALOXI® can help patients with acute or delayed Chemo-Induced Nausea and Vomiting.

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

+ EXPAND- COLLAPSE

Indication in Pediatrics

ALOXI® injection 20mcg/kg (max 1.5mg) is indicated in patients ≥ 1 month up to 17 years of age, for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy.

Indication in Adults

ALOXI® injection 0.25 mg is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

Important Safety Information

Contraindications

  • ALOXI® is contraindicated in patients known to have hypersensitivity to the drug or any of its components
  • Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists
  • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone, but particularly with the use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue ALOXI® and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ALOXI® is used concomitantly with other serotonergic drugs

     

    For more information about ALOXI®, 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. 

    ALOXI® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.
    Distributed and marketed by Eisai Inc and Helsinn Therapeutics (U.S.), Inc.
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