2012 Medicare Reimbursement Information Lantheus Medical Imaging

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2 If you have questions regarding reimbursement for Lantheus Medical Imaging products, call Randy VanCoughnett at or Reimbursement consists of three elements: Coding, coverage and payment. Coding: There must be a CPT code or HCPCS code that accurately describes the service performed and/or the drugs provided. Coverage: The existence of CPT and/or HCPCS codes used to report the services performed or items furnished does not guarantee coverage for procedures, supplies or drugs. Medicare only covers a procedure, drug or supply when it is medically necessary. Providers should obtain and follow the policies and guidelines published by Medicare in the Local and National Coverage Determinations. Payment: If the proper codes exist and there is coverage established, Medicare must set a payment amount for the drugs, supplies and or procedures in order for providers to receive payment. Most payment amounts are determined by CMS nationally. There are differences in procedure payment amounts from region to region to reflect geographic differences in provider costs. Documentation: When radiopharmaceuticals or contrast agents are reported providers must document in the medical record the name of the drug and the amount administered. Lantheus Medical Imaging, Inc. cannot guarantee coverage or payment for products or procedures. Payer policies can vary widely. For more specific information contact the payer directly in order to obtain up to date coverage, coding and payment information. 2

3 DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension INDICATIONS Activated DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. CONTRAINDICATIONS Do not administer DEFINITY to patients with known or suspected right-to-left, bidirectional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren. IMPORTANT SAFETY INFORMATION WARNING: Serious Cardiopulmonary Reactions Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [See WARNINGS AND PRECAUTIONS (5.1)]. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes DEFINITY administration [See CONTRAINDICATIONS (4)]. Always have resuscitation equipment and trained personnel readily available. In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration [See ADVERSE REACTIONS (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [See Postmarketing Experience (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease. Please see full prescribing information on pages 11-13, including boxed WARNING regarding serious cardiopulmonary reactions. 3

4 ABLAVAR gadofosveset trisodium INDICATIONS: ABLAVAR is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease. CONTRAINDICATIONS: History of a prior allergic reaction to a gadolinium-based contrast agent. IMPORTANT SAFETY INFORMATION: WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR < 30 ml/min/1.73m 2 ), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended ABLAVAR dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration. ABLAVAR Injection: As with other contrast media, the possibility of serious or lifethreatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered. As with other gadolinium based contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function. In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes following ABLAVAR administration. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for arrhythmias due to baseline QTc prolongation. Have emergency resuscitative equipment available prior to and during ABLAVAR administration. Please see full Prescribing Information on pages 14-15, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF). 4

5 Cardiolite (Kit for the Preparation of Technetium Tc 99m Sestamibi for Injection) Indications and Usage: Cardiolite, Kit for the Preparation of Technetium Tc99m Sestamibi for injection, is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Cardiolite evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent s labeling). It is usually not possible to determine the age of myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Important Safety Information: Exercise and pharmacologic stress testing should be performed only under the supervision of a qualified physician. Cardiolite has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell. Please see Full Prescribing Information on pages Medicare 2012 HOPPS values listed in this booklet are based on data from CMS regulation CMS-1525-FC at: Overview of Medicare Payment Settings Contrast Agents & Radiopharmaceuticals Medicare Hospital Inpatients Medicare Hospital Outpatients Physician Offices and IDTFs Hospital reimbursement is based on DRG payment. There is no additional payment for drugs or imaging procedures. Imaging procedures paid separately. Contrast agent & diagnostic radiopharmaceutical payments are packaged with the procedure payment and not paid separately. Imaging procedures paid separately. Contrast agents separately reimbursed based on ASP. Radiopharmaceuticals reimbursed separately based on AWP or invoice. 5

6 DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension Medicare Hospital Outpatients For procedures in the hospital outpatient setting Medicare has packaged the payment for echocardiography contrast agents into the payment for the echocardiography procedure. Medicare published a list of ten unique C codes, one for each echocardiography procedure to report when contrast echo is performed. Hospitals must report one of these C codes in order to be reimbursed for the packaged combination of the contrast agent and the echo procedure. Hospitals should report the packaged drug HCPCS code in addition to the C code in order for CMS to obtain cost and charge data. DEFINTY should be reported as Q9957 perflutren lipid microsphere, two units per vial. Q9957 will not be paid as a separate line item, contrast payment is packaged with the appropriate C code. For Medicare Hospital Outpatients TTE rest echo without contrast CPT code TTE rest echo with contrast HCPCS code C Medicare Payment for Hospital Outpatients Echocardiography (TTE) with and without contrast Echocardiography transthoracic, real time with image documentation (2D), includes M-mode recording, when performed, complete, with spectral Doppler echocardiography and with color flow Doppler echocardiography. Transthoracic echocardiography with contrast, or without contrast followed by with contrast, real-time with image documentation (2D) includes M-Mode recording, when performed complete, with spectral Doppler echocardiography, and with color flow Doppler echocardiography Medicare Hospital Outpatient Payment 1 $ $ Most non Medicare private payers recognize and reimburse for contrast echo studies utilizing the appropriate C codes. Providers should always confirm the coding, coverage and payment in their contracts with their payers. Contrast-enhanced echocardiography procedures can involve: Supplies such as intravenous infusion sets, Equipment such as intravenous poles and infusion control devices, Clinical labor such as nursing or other appropriate personnel involved with starting an intravenous line and administering contrast agents. These resources are not required when performing non-contrast echocardiography. Hospitals should consider these differences when determining charges AMA Current Procedural Terminology

7 DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension Medicare Physician Office and IDTF Setting HCPCS Q9957 Injection, perflutren lipid microspheres, per ml. Q9957 HCPCS code for DEFINITY. DEFINITY is a single use vial. When reporting HCPCS Q9957 there are two units per vial of DEFINITY. DEFINITY is reimbursed separately by Medicare Part B in the physician office setting. The payment allowance limits are updated each quarter and listed on the CMS website at For the 1st quarter of 2012 the Part B Medicare reimbursement was $61.16 per unit, two units per vial 1. This payment amount is updated each quarter. DEFINITY is a single use vial. Medicare allows reimbursement for the amount injected plus the amount discarded when providers use single use vials. Some Part B Medicare Carriers may require the use of the JW modifier to document the amount of a single use vial that is discarded 2. Check with your local carrier to determine whether they require use of the JW modifier. For more reimbursement information go to the ASE website Non Medicare private payers usually reimburse echo contrast agents separately in the physician office and IDTF setting. Providers must check their contracts and / or contact their private payers to confirm coding, coverage and payment amounts

8 Medicare Hospital Outpatients ABLAVAR gadofosveset trisodium MRA contrast agents are not paid separately by Medicare unless they have pass through status. Payment for non pass through contrast agents is packaged with the MRA procedure payment for Medicare hospital outpatients. Providers should report charges for packaged contrast agents to CMS so that CMS can obtain the cost and charge data necessary to set future payments. HCPCS A gadofosveset trisodium per ml Medicare Physician Office & Independent Diagnostic Testing Facilities ABLAVAR is reimbursed separately by Medicare Part B in the physician office setting. The payment allowance limits are updated each quarter and listed on the CMS website at For the 1st quarter of 2012 the Part B Medicare reimbursement was $ per ml. Fourth quarter Part B non hospital 2011 payment allowance limit per vial Payment allowance limit 10 ml vial $ Payment allowance limit 15 ml vial $ This payment allowance limit is updated by CMS each quarter. HCPCS A9583 Injection, gadofosveset trisodium 1 ml. ABLAVAR is a single use vial. When reporting HCPCS A9583 there are 10 units in a 10 ml single use vial of ABLAVAR and 15 units in a 15 ml single use vial. ABLAVAR is a single use vial. Medicare allows reimbursement for the amount injected plus the amount discarded when providers use single use vials. Some Part B Medicare Carriers may require the use of the JW modifier to document the amount of a single use vial that is discarded 2. Check with your local carrier to determine whether they require use of the JW modifier. Non Medicare private payers usually reimburse contrast agents separately in the physician office and IDTF setting. Providers must check their contracts and / or contact their private payers to confirm coding, coverage and payment amounts

9 2012 Medicare Reimbursement for Nuclear Cardiology Myocardial perfusion imaging, tomographic (SPECT) (including attenuation correction, qualitative or quantitative wall motion, ejection fraction by first pass or gated technique, additional quantification, when performed); multiple studies at rest and / or stress (exercise or pharmacologic) and / or redistribution and / or rest reinjection. Medicare Hospital Outpatients Payments 2012 Payment SPECT, wall motion, ejection fraction $ includes payment for radiopharmaceutical Cardiovascular stress test $ PET Myocardial Perfusion Imaging, includes payment for radiopharmaceutical $ Medicare Physician Office Setting Global RVUs includes SPECT, wall motion, ejection fraction includes SPECT, wall motion, ejection fraction includes SPECT, wall motion, ejection fraction PET myocardial perfusion imaging Carrier Priced Cardiolite A9500 Technetium Tc-99m sestamibi per dose A9500 Hospital Outpatients Medicare radiopharmaceutical payment packaged with primary procedure. A9500 Office and IDTF setting - Payment is based on 95% of the AWP, carrier priced or invoice. Check with your local contractor for local payment methodology &sortByDID=4&sortOrder=descending&itemID=CMS &intNumPerPage=10 3, Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 p Federal Register / Vol. 75, No. 226 / Wednesday, November 24,

10 2012 HCPCS Information Product HCPCS Units Comments Cardiolite Kit for the Preparation of Technetium Tc99m Sestamibi for Injection A9500 Per Dose HOPPS payment bundled with primary procedure. Office setting payment by invoice or 95% of AWP. NDC per dose Thallous Chloride Thallium 201 Injection A9505 Per mci HOPPS payment bundled with primary procedure. Office setting payment by invoice or 95% of AWP. NDC per mci DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension Q9957 Per ml. Two ml per vial HOPPS payment for Q9957 bundled with primary procedure. Office setting payment based on Average Selling Price updated quarterly by CMS. NDC Gallium Citrate Ga 67 Injection A9556 Per mci HOPPS payment bundled with primary procedure. Office setting payment by invoice or 95% of AWP. NDC Varies by size Neurolite Kit for the Preparation of Technetium Tc99m bicisate for Injection A9557 Per Dose HOPPS payment bundled with primary procedure. Office setting payment by invoice or 95% of AWP. NDC per dose Xenon Xe 133 Gas A9558 Per 10mCi HOPPS payment bundled with primary procedure. Office setting payment by invoice or 95% of AWP. NDC Varies by size ABLAVAR gadofosveset trisodium A9583 Per ml HOPPS payment bundled with primary procedure. Reimbursement by ASP Medicare part B. NDC (10 ml vial) NDC (15 ml vial) ABLAVAR, Cardiolite, DEFINITY and corporate logo display are registered trademarks of Lantheus Medical Imaging, Inc. Any unlicensed use of these trademarks is expressly prohibited under the U.S. Trademark Act v1. 10

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