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® New HCPCS Code for EOVIST (gadoxetate disodium) Injection Effective January 1, 2010 A9581 - Injection, gadoxetate disodium, 1 mL The Centers for Medicare and Medicaid Services (CMS) has announced the new HCPCS code for EOVIST Injection. The new code, A9581, is available for billing and payment purposes effective for claims with dates of service beginning January 1, 2010. A9581 will be recognized by all payers – government and private – and should be used in all care settings. The new code will replace the codes currently utilized for billing EOVIST, including the unlisted drug code J3490, and the EOVIST pass-through code C9246 used by hospital outpatient providers. When billing for EOVIST for services on or after January 1, 2010: · · Enter the A9581 code in Field 24D on the CMS-1500 Form or record locator 44 on the CMS-1450 form. If appropriate, bill for a quantity of 10 units in Field 24G or record locator 46 to reflect the total mL dosage. Medicare provides payment for the amount of drug or biological discarded along with the amount administered, up to the amount of the drug or biological as indicated on the vial or package label, when the product originated from a single-dose vial. The patient’s medical record should be clearly documented with the date, time, amount of contrast administered, the amount discarded, and the source of the contrast was from a single-dose vial. EOVIST is supplied in 10 mL singledose vials, and therefore any discarded portion may be billed to Medicare. Local Medicare contractors may require the use of the modifier JW to identify unused product from single-dose vials that are appropriately discarded. Your local Medicare contractor can provide guidance on the use of the JW modifier. Freestanding Facilities, IDTFs, and Physician Offices Medicare provides separate payment for contrast agents in the freestanding center, IDTF, and physician office setting. Payment for contrast is made according to the payment rules of drugs and biologicals, and will continue to be based on ASP +6% for all contrast agents, including EOVIST Injection. EOVIST claims for dates of service through December 31, 2009 should continue to be billed to all payers using the unlisted drug code, J3490. Supplemental information is required on claims when billing with J3490 to allow for claims processing. Medicare contractors will require the drug name (gadoxetate disodium), dosage amount, and route of administration (IV) to be included in Field 19 on claims for EOVIST. To confirm individual contractor billing requirements, contact the Reimbursement Helpline. Hospital Outpatient Departments EOVIST Injection was granted pass-through status by Medicare effective January 1, 2009 with HCPCS code C9246 (Injection, gadoxetate disodium, per mL), and pass-through status will continue through 2010 with the new HCPCS code, A9581. Hospital outpatient departments will continue to receive separate payment from Medicare for EOVIST when billed with A9581 in 2010, however there will be a payment offset applied. For more information on this offset please contact the Reimbursement Helpline. EOVIST claims for dates of service through December 31, 2009 should continue to be billed using C9246. Private Payer and Medicaid Claims Private payers and Medicaid programs will accept the new A9581 code for EOVIST in 2010. Private payers and Medicaid programs typically require the NDC (National Drug Code) to be reported on claims for physician administered drugs. Please follow your payers’ existing billing guidelines for the submission of drug claims, and include the EOVIST NDC on claims as recommended by each payer. The EOVIST NDC is: 50419-0320-01. Remember that EOVIST claims for dates of service through December 31, 2009 should continue to be billed to private payers and Medicaid programs using the unlisted drug code, J3490. Supplemental information is required on the claim forms when billing with J3490 to allow for claims processing. Include a description of the service (drug name, dosage amount, route of administration) along with the NDC. Note that each payer may have specific claims filing requirements, so it is recommended to check with the payer before submitting claims. For more information on specific payer guidelines, contact the Reimbursement Helpline. Questions? The Reimbursement Helpline is available to answer your questions, or provide payer specific research. Call 800-423-7539 Monday through Friday 9:00 am until 5:00 pm Eastern Time to speak to a reimbursement specialist, or email us at [email protected]. To view the 2010 HCPCS File, please click on the 2010 Alpha-Numeric HCPCS File on the CMS website: http://www.cms.hhs.gov/hcpcsreleasecodesets/anhcpcs/List.asp INDICATIONS AND USAGE EOVIST® (gadoxetate disodium) Injection is a gadolinium-based contrast agent indicated for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease. IMPORTANT SAFETY INFORMATION WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with: • acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or • acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration. The possibility of serious or life-threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered. The most common adverse reactions observed in clinical trials at the recommended dose included feeling hot, nausea and headache. Please see full Prescribing Information in link below http://berlex.bayerhealthcare.com/html/products/pi/Eovist_PI.pdf The coding, billing and payment information provided by the Reimbursement Helpline (sponsored by Bayer HealthCare Pharmaceuticals) is advice only, and is not a guarantee of payment or reimbursement from any insurer for procedures, services or products. Please contact the payer for specific payment information.