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MedicareReimbursement Information2020Please see Indications and Important Safety Informationon page 11 and the full Prescribing Information, includingboxed WARNING regarding serious cardiopulmonaryreactions on pages 12-14.
Questions regarding reimbursement for Lantheus Medical Imaging products?Call Randy VanCoughnett at 978-436-7995 oremail randy.vancoughnett@lantheus.com.DEFINITY, Lantheus Medical Imaging and the corporate logo are registered trademarks of Lantheus Medical Imaging, Inc.Any unlicensed use of these trademarks is expressly prohibited under the U.S. Trademark Act 275336 v1.2
2020 Medicare Reimbursement InformationTABLE OF CONTENTS1. Basic Reimbursement Background and Settings.4 - 52. DEFINITY Hospital Outpatient Setting andAmbulatory Payment Classification (APC) Payments.63. Hospital Outpatient Claim Form Contrast Echo Example.74. Full Descriptors: Echo C-codes andCurrent Procedural Terminology (CPT ) Codes.85. DEFINITY Non Hospital Setting.96. Echo National Average Payments for Physician Officeand Independent Diagnostic Testing Facility (IDTF).107. Indications, Contraindications and Important Safety Information.118. Full Prescribing Information.12 - 143
2020 Medicare Reimbursement Information1. Basic Reimbursement Background and SettingsCPT – Current Procedural Terminology American Medical Association’s five digit numeric codes used to report medical procedures andservices.HCPCS - Healthcare Common Procedure Coding System Level I HCPCS codes are American Medical Association’s Current Procedural Terminology (CPT). Level II HCPCS codes are alphanumeric five digit codes primarily used to identify contrastagents, radiopharmaceuticals, supplies and devices.HCPCS code for DEFINITY Q9957 Injection, perflutren lipid microspheres, per mL. There are two units per vial of DEFINITY .C-codes Unique, temporary HCPCS codes created by Medicare and used only for hospital outpatients.This is often done when no other appropriate code exists.Q-codes Temporary codes created by Medicare to identify items not assigned a CPT code. Many drugs,supplies and biologicals are assigned Q codes.NDC codes – National Drug Code A unique numeric code to identify drugs. The first segment of numbers identifies the labeler ormanufacturer, the second segment identifies the product and the third identifies the package.NDC codes DEFINITY NDC 4 vial kit11994-011-04 NDC 16 vial kit11994-011-164
Lantheus Medical ImagingEchocardiography codes1,2 CPT 93306 – TTE “rest” echo completeEchocardiography, transthoracic, real-time with image documentation (2D),includes M-mode recording, when performed, complete, with spectral Dopplerechocardiography, and with color flow Doppler echocardiography. HCPCS C8929 TTE “rest” echo complete with contrastTransthoracic 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. HCPCS C8929 - CMS “short descriptor”TTE w or w/o fol wcon, DopplerJW modifier - The JW modifier is not required for packaged drugs such as DEFINITY for MedicareHospital Outpatients.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 toobtain up to date coverage, coding and payment italOutpatientsPhysician OfficesandIDTFsHospital reimbursement isbased on DiagnosticallyRelated Group(DRG) payment.Payment for non pass throughcontrast agents is packaged withthe imaging procedure payment.Contrast agents arepaid in addition toand separatelyfrom procedure.There is no additionalpayment for drugs orimaging procedures.When separate payment is madefor a pass through drug an APCoffset is subtracted from the finalpayment so as to not pay twicefor the pass through drug.Reimbursement for hospitaloutpatient procedures is basedon past cost analysis by Medicare.5Contrast agents are reimbursedbased on Medicare’s AverageSelling Price listings.
2020 Medicare Reimbursement Information2. DEFINITY Hospital Outpatient Setting and APC Payments3In the Medicare Hospital Outpatient setting DEFINITY is reimbursed, however, the payment ispackaged with the imaging procedure payment.93306 TTE complete with Doppler and color flow without contrast. 481.53C8929 TTE complete with Doppler and color flow with contrast. 680.74C8929, with contrast, is reimbursed 199.21 higher than 93306, without contrast, due to the highercost to perform a contrast echo.Hospitals must bill for the appropriate C-code when reporting an echo with DEFINITY in order toreceive the packaged payment for DEFINITY . If a C-code is not billed there will be no payment forcontrast. Q9957 is not paid as a separate item.When billing echo procedures, report the appropriate C-code for an echo with contrast or theappropriate CPT code for an echo without contrast. Do not report both. When using DEFINITY ,hospitals should report Q9957 two units per vial. It is not paid separately but this allows Medicareto collect cost and charge data in order to set future payments.APCs ECHO PROCEDURES - WITHOUT CONTRAST3APCs ECHO PROCEDURES - WITH CONTRAST3APC 5523 - 233.01Level 3 Imaging Without ContrastAPC 5572 - 381.81Level 2 Imaging With Contrast93307 TTE complete w/o Doppler and color flow93308 TTE follow up or limited(61 total imaging procedure codes in APC 5523)C8924 TTE follow up or limited with contrast(60 total imaging with contrast codes in APC 5572)APC 5573 - 680.74Level 3 Imaging With ContrastAPC 5524 - 481.53Level 4 Imaging Without Contrast93303 TTE congenital, complete93304 TTE congenital follow up or limited93306 TTE complete with Doppler and color flow93312 TEE include placement, acq, inter, report93313 TEE placement only93315 TEE cong, placement, acq, inter, report93316 TEE congenital placement only93318 TEE monitor, placement, acq, inter93350 Stress TTE (w/o ECG monitoring)93351 Stress TTE (includes ECG monitoring)(18 total imaging procedure codes in APC 5524)C8921 TTE congenital complete with contrastC8922 TTE congenital follow up or limited withcontrastC8923 TTE complete w/o Doppler, CF with contrastC8925 TEE placement, acq, inter, report with contrastC8926 TEE congenital placement, image, inter, reportwith contrastC8927 TEE monitor, placement, acq, inter, w/ contrastC8928 Stress TTE (no ECG monitoring) with contrastC8929 TTE comp. with Dop., color flow with contrastC8930 Stress TTE (with ECG monitoring) with contrast(22 total Imaging with contrast codes in APC 5573)93356 Myocardial strain imaging add on code. (Notassigned to an APC. No separate payment. HOPPSpayment packaged)0439T Myocardial contrast perfusion echo (Notassigned to an APC. No separate payment. HOPPSpayment packaged)For complete code descriptors see page 86
Lantheus Medical Imaging3. Claim Form7
2020 Medicare Reimbursement Information4. Complete code descriptors.Without contrast left column, with contrast right column93303Transthoracic echocardiography for congenital cardiac anomalies;completeC8921Transthoracic echocardiography with contrast, or without contrastfollowed by with contrast, for congenital cardiac anomalies;complete93304Transthoracic echocardiography for congenital cardiac anomalies;follow-up or limited studyC8922Transthoracic echocardiography with contrast, or without contrastfollowed by with contrast, for congenital cardiac anomalies;follow-up or limited study93306Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete,with spectral Doppler echocardiography, and with color flowDoppler echocardiographyC8929Transthoracic echocardiography with contrast, or without contrastfollowed by with contrast, real-time with image documentation(2D), includes M-mode recording, when performed, complete, withspectral Doppler echocardiography, and with color flow Dopplerechocardiography93307Echocardiography, transthoracic, real-time, with image documentation (2D), includes M-mode recording, when performed,complete, without spectral or color Doppler echocardiographyC8923Transthoracic echocardiography with contrast, or without contrastfollowed by with contrast, real-time with image documentation(2D), includes M-mode recording, when performed, complete,without spectral or color Doppler echocardiography93308Echocardiography, transthoracic, real-time, with imagedocumentation (2D), includes M-mode recording, whenperformed, follow-up or limited studyC8924Transthoracic echocardiography with contrast, or without contrastfollowed by with contrast, real-time with image documentation(2D), includes M-mode recording, when performed, follow-up orlimited study93312Echocardiography, transesophageal, real-time with imagedocumentation (2D) (with or without M-mode recording); includingprobe placement, image acquisition, interpretation and reportC8925Transesophageal echocardiography (TEE) with contrast, or withoutcontrast followed by with contrast, real-time with image documentation (2D) (with or without M-mode recording); including probeplacement, image acquisition, interpretation and report93315Transesophageal echocardiography for congenital cardiacanomalies; including probe placement image acquisition,interpretation and reportC8926Transesophageal echocardiography (TEE) with contrast, or withoutcontrast followed by with contrast, for congenital cardiac anomalies;including probe placement, image acquisition, interpretation andreport93318Echocardiography, transesophageal (TEE) for monitoring purposes,including probe placement, real-time 2 - dimensional imageacquisition and interpretation leading to ongoing (continuous)assessment of (dynamically changing) cardiac pumping functionand to therapeutic measures on an immediate time basisC8927Transesophageal echocardiography (TEE) with contrast, or withoutcontrast followed by with contrast, for monitoring purposes, including probe placement, real-time 2-dimensional image acquisitionand interpretation leading to ongoing (continuous) assessment of(dynamically changing) cardiac pumping function and to therapeuticmeasures on an immediate time basis93350Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, during restand cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and reportC8928Transthoracic echocardiography with contrast, or without contrastfollowed by with contrast, real-time with image documentation(2D), includes M-mode recording, when performed, during rest andcardiovascular stress test using treadmill bicycle exercise and orpharmacologically induced stress, with interpretation and report93351Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, during restand cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and report;including performance of continuous electrocardiographic monitoring, with supervision by a physician or other qualified health careprofessional.C8930Transthoracic echocardiography, with contrast, or without contrastfollowed by with contrast, real-time with image documentation(2D), includes M-mode recording, when performed, during rest andcardiovascular stress test using treadmill, bicycle exercise and/orpharmacologically induced stress, with interpretation and report;including performance of continuous electrocardiographicmonitoring, with physician supervision93356Myocardial strain imaging using speckle tracking-derived assessment of myocardial mechanics (List separately in addition to codesfor echocardiography imaging)NAAdd on code. Use in conjunction with 93303, 93304, 93306, 90337,93308, 93350, 93351. Report once per session.NA0439T8Myocardial perfusion contrast echocardiography, at rest or withstress, for assessment of myocardial ischemia or viability. (Listseparately in addition to code for primary procedure) SunsetJanuary, 2022. (Use 0439T in conjunction with 93306, 90337,93308 93350, 93351)
Lantheus Medical Imaging5. DEFINITY Non Hospital SettingHCPCS Q9957 Injection, perflutren lipid microspheres, per mL Q9957 HCPCS code for DEFINITY .When reporting HCPCS Q9957 there are two units per vial of DEFINITY .Medicare Part B payment for Q1 20204 - 48.20 per unit (updated quarterly)DEFINITY is a single use vial.DEFINITY is reimbursed separately by Medicare Part B in the physician office setting. Thepayment allowance limits are updated each quarter and listed on the CMS website e/.Non Medicare, private payers usually reimburse echo contrast agents separately in the physicianoffice and IDTF setting. It is not unusual for a private payer to reimburse contrast agents at a ratethat is higher than Medicare, however, providers must check their contracts and/or contact theirprivate payers to confirm coding, coverage and payment amounts for contrast agents.DEFINITY is a single use vial. Medicare allows reimbursement for the amount injected plus theamount discarded for single use vials. For DEFINITY one mL is equal to one billing unit. The vialcontains more than one mL and less than two mLs, therefore there are two units per vial. Whenreporting drug units providers round up to the next whole unit when a unit of measure is exceeded.Category lll codes such as 0439T are contractor priced by Medicare under the physician feeschedule. Providers should check with their local Medicare Part B contractor for paymentamounts and coverage information.The interpreting physician must perform the test that was ordered by the treating / referringphysician or they must contact the treating physician to change the order. However, theinterpreting physician can determine the design of the test without notifying the treatingphysician for such items as the use or non use of contrast.In the Medicare Benefit Policy Manual Chapter 15 section 80.6.4 - Rules for Testing FacilityInterpreting Physician to Furnish Different or Additional Tests it states that6:“Unless specified in the order, the interpreting physician may determine, without notifying thetreating physician/practitioner, the parameters of the diagnostic test (e.g., number of radiographicviews obtained, thickness of tomographic sections acquired, use or non-use of contrast media)”.9
2020 Medicare Reimbursement Information6. 2020 National Average Payments for Physician Office IDTF5TC - Technical Component, 26 - Professional Component, G - GlobalCPTShort DescriptorPaymentCPTShort DescriptorPayment933039330393303GTC26TTE limited congenitalTTE limited congenitalTTE limited congenital 237.47 172.15 65.329331526TEE cong. acq, inter, report 132.459331726TEE acq, inter, report only 94.19933049330493304GTC26TTE limitedTTE limitedTTE limited 163.12 125.59 37.539331826TEE monitoring 107.19933069330693306GTC26TTE comp, Dop, CFTTE comp, Dop, CFTTE comp, Dop, CF 211.49 136.42 75.07933209332093320GTC26Doppler echoDoppler echoDoppler echo 54.50 35.73 18.77933079330793307GTC26TTE comp, w/o Dop, CFTTE comp, w/o Dop, CFTTE comp, w/o Dop, CF 144.00 97.80 46.19933219332193321GTC26Doppler echo F/U or limitedDoppler echo F/U or limitedDoppler echo F/U or limited 27.07 19.49 7.58933089330893308GTC26TTE F/U or limitedTTE F/U or limitedTTE F/U or limited 100.69 74.34 26.35933259332593325GTC26Doppler color flow add-onDoppler color flow add-onDoppler color flow add-on 25.26 22.01 3.25933129331293312GTC26TEE place acq,int, rep.TEE place acq,int, rep.TEE place acq,int, rep. 251.18 138.58 112.60933509335093350GTC26Stress TTE onlyStress TTE onlyStress TTE only 193.44 120.54 72.909331493314933149335693356GTC26GGTEE acq, inter, reportTEE acq, inter, reportTEE acq, inter, reportMyocardial strain image - FMyocardial strain image - NF 241.08 147.60 93.47 12.27 40.78933519335193351GTC26Stress TTE with exerciseStress TTE with exerciseStress TTE with exercise 239.27 151.94 87.34933520439TGUse of contrast at stressMyocardial perfusion echoPayment amounts vary from location to location.See CMS physician fee schedule to confirm your local payment amounts /license-agreement.aspxF – Facility, NF – Non-FacilityFor complete text for CPT code descriptors see page 8.10 34.29contractor
Lantheus Medical Imaging7. Indications, Contraindications and Important Safety InformationINDICATIONSActivated DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients withsuboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the leftventricular endocardial border.CONTRAINDICATIONSDo not administer DEFINITY to patients with known or suspected hypersensitivity to perflutren.IMPORTANT SAFETY INFORMATIONWARNING: Serious Cardiopulmonary ReactionsSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or followingperflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Most seriousreactions 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 postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reportedduring 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 Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drugexposure due to the presence of underlying cardiopulmonary disease.DEFINITY, Lantheus Medical Imaging and the corporate logoare registered trademarks of Lantheus Medical Imaging, Inc.Any unlicensed use of these trademarks is expresslyprohibited under the U.S. Trademark Act 275336 v1.11
2020 Medicare Reimbursement Information515987-0318 331 Treble Cove RoadN. Billerica, Massachusetts 01862 USAFOR INTRAVENOUS USEHIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all of the information neededto use DEFINITY safely and effectively. See full prescribinginformation for DEFINITY.DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension,for intravenous useInitial U.S. Approval: 2001WARNING: SERIOUS CARDIOPULMONARY REACTIONSSee full prescribing information for complete boxed warningSerious cardiopulmonary reactions, including fatalities, haveoccurred uncommonly during or following perflutren-containingmicrosphere administration (5.1). Most serious reactions occurwithin 30 minutes of administration. Assess all patients for the presence of any condition thatprecludes DEFINITY administration (4). Always have resuscitation equipment and trained personnelreadily available.---------------- INDICATIONS AND USAGE -------------DEFINITY is an ultrasound contrast agent indicated for use inpatients with suboptimal echocardiograms to opacify the leftventricular chamber and to improve the delineation of the leftventricular endocardial border.------------ DOSAGE AND ADMINISTRATION ----------DEFINITY may be injected by either an intravenous (IV) bolus orinfusion. The maximum dose is either two bolus doses or onesingle intravenous infusion.The recommended bolus dose for activated DEFINITY is 10 microliters (microL)/kg of the activated product by intravenous bolus injection within 30 to 60 seconds, followed by a 10 mL salineflush. If necessary, a second 10 microliters (microL)/kg dose followed by a second 10 mL saline flush may be administered 30minutes after the first injection to prolong contrast enhancement.The recommended infusion dose for activated DEFINITY is via anIV infusion of 1.3 mL added to 50 mL of preservative-free saline.The rate of infusion should be initiated at 4 mL/minute, but titrated as necessary to achieve optimal image enhancement, not toexceed 10 mL/minute.----------- DOSAGE FORMS AND STRENGTHS -------DEFINITY is supplied as a single use 2 mL clear glass vial containing clear liquid in packages of four (4) and sixteen (16) single-usevials.------------------- CONTRAINDICATIONS ---------------Do not administer DEFINITY to patients with known or suspected:Hypersensitivity to perflutren.------------ WARNINGS AND PRECAUTIONS ---------Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration. (5.1)Serious acute hypersensitivity reactions have occurred in patientswith no prior exposure to perflutren-containing microsphere products (5.2, 6).Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY administration and monitor all patients for acute reactions (5.1, 5.2).----------------- ADVERSE REACTIONS ----------------The most common adverse reactions ( 0.5%) are headache,back/renal pain, flushing, nausea, chest pain, injection site reactions, and dizziness (6).To report SUSPECTED ADVERSE REACTIONS, contactLantheus Medical Imaging, Inc. at 1-800-362-2668 or FDAat 1-800-FDA-1088 or www.fda.gov/medwatch.See 17 for Patient Counseling Information.Revised: 12/2018FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Important Administration Instructions2.2 Dosage2.3 Imaging Guidelines2.4 DEFINITY Activation, Preparation and HandlingInstructions3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Serious Cardiopulmonary Reactions5.2 Hypersensitivity Reactions5.3 Systemic Embolization5.4 Ventricular Arrhythmia Related to High Mechanical Index6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility14 CLINICAL STUDIES14.1 Echocardiography14.2 Pulmonary Hemodynamic Effects16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage and Handling17 PATIENT COUNSELING INFORMATION* Sections or subsections omitted from the full prescribinginformation are not listed.FULL PRESCRIBING INFORMATIONWARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, haveoccurred uncommonly during or following perflutren-containingmicrosphere 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 thatprecludes DEFINITY administration [see Contraindications(4)]. Always have resuscitation equipment and trained personnelreadily available.1 INDICATIONS AND USAGEActivated DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improvethe delineation of the left ventricular endocardial border.2 DOSAGE AND ADMINISTRATION2.1 Important Administration Instructions DEFINITY is intended for administration only after activation inthe VIALMIX apparatus. Before injection, this product must beactivated and prepared according to the instructions outlinedbelow. The VIALMIX apparatus should be ordered from Lantheus Medical Imaging, 331 Treble Cove Road, North Billerica,MA, 01862. For customer orders call 1-800-299-3431. DEFINITY may be injected by either an intravenous (IV) bolusor infusion. Do not administer DEFINITY by intra-arterial injection [see Warnings and Precautions (5.3)]. The maximum dose is either two bolus doses or one singleintravenous infusion. The safety of bolus and infusion dosing incombination or in sequence, has not been studied.2.2 DosageBolusThe recommended bolus dose for activated DEFINITY is 10 microliters (microL)/kg of the activated product by intravenous bolus injection within 30 to 60 seconds, followed by a 10 mL salineflush. If necessary, a second 10 microliters (microL)/kg dose followed by a second 10 mL saline flush may be administered 30minutes after the first injection to prolong contrast enhancement.InfusionThe recommended infusion dose for activated DEFINITY is via anIV infusion of 1.3 mL added to 50 mL of preservative-free saline.The rate of infusion should be initiated at 4 mL/minute, but titratedas necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.122.3 Imaging GuidelinesAfter baseline non-contrast echocardiography is completed, setthe mechanical index for the ultrasound device at 0.8 or below[see Warnings and Precautions (5.4)]. Then inject activated DEFINITY (as described above) and begin ultrasound imaging immediately. Evaluate the activated DEFINITY echocardiogram imagesin combination with the non-contrast echocardiogram images.In a crossover trial of 64 patients randomized to both bolus andinfusion, the duration of clinically useful contrast enhancement forfundamental imaging was approximately 3.4 minutes after a 10microL/kg bolus and was approximately 7.1 minutes during thecontinuous infusion of 1.3 mL activated DEFINITY in 50 mL salineat a rate of 4 mL/min.2.4 DEFINITY Activation, Preparation and Handling Instructions1. Allow the vial to warm to room temperature before startingthe activation procedure.2. Activate DEFINITY by shaking the vial for 45 seconds usinga VIALMIX.Note: illustrations of this procedure are contained in theVIALMIX User’s Guide.Do not use this drug unless it has completed a full 45 second activation cycle in the VIALMIX. DEFINITY will notbe properly activated unless the full 45 second activationcycle is completed. Do not reactivate the vial if VIALMIXdid not complete a full 45 second cycle. Do not reactivatea successfully activated DEFINITY vial (see step 3). Donot use a VIALMIX that is not functioning properly. Referto the VIALMIX User’s Guide for the “VIALMIX calibrationand replacement procedures” to ensure that a properlyfunctioning VIALMIX is used.3. Immediately after activation in the VIALMIX, activatedDEFINITY appears as a milky white suspension and may beused immediately after activation. If the product is not usedwithin 5 minutes of VIALMIX activation, the microspheresshould be resuspended by 10 seconds of hand agitation byinverting the vial before the product is withdrawn in a syringe. The activated DEFINITY may be used for up to 12hours from the time of VIALMIX, but only after the microspheres are resuspended by hand agitation. Store the activated DEFINITY at room temperature in the original productvial.4. Invert the vial and withdraw the activated milky white suspension using the Intellipin (Dispensing Pin), the PINSYNC(Vented Vial Adapter 13mm), or 18 to 20 gauge syringe needle. Withdraw the material from the middle of the liquid inthe inverted vial. Do not inject air into the DEFINITY Vial.5. Use the product immediately after its withdrawal from thevial; do not allow the product to stand in the syringe.For single use only: DEFINITY does not contain bacterial preservative. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. It is essential to follow directions for activationof DEFINITY carefully and to adhere to strict aseptic proceduresduring preparation.3DOSAGE FORMS AND STRENGTHSDEFINITY is supplied as a single use 2 mL clear glass vial containing a clear liquid in packages of four (4) and sixteen (16) single-use vials.Prior to activation, the headspace of each vial contains 6.52 mg/mL octafluoropropane and the clear liquid contains 0.75mg/mL ofa lipid blend. After activation, each vial contains a maximum of1.2 X 1010 perflutren lipid microspheres, and about 150 microL/mL(1.1 mg/mL) octafluoropropane [see Description (11)].4CONTRAINDICATIONSDo not administer DEFINITY to patients with known or suspected: Hypersensitivity to perflutren [see Warnings and Precautions (5)].5WARNINGS AND PRECAUTIONS5.1 Serious Cardiopulmonary ReactionsSerious cardiopulmonary reactions including fatalities have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutesof administration. The risk for these reactions may be increasedamong patients with unstable cardiopulmonary conditions (acutemyocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias). Always have cardiopulmonary resuscitation personneland equipment readily available prior to DEFINITY administrationand monitor all patients for acute reactions.The reported reactions include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation,tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor,wheezing, loss of consciousness, and convulsions [see AdverseReactions (6)].
Lantheus Medical Imaging5.2 Hypersensitivity ReactionsIn pos
Myocardial strain imaging using speckle tracking-derived assess-ment of myocardial mechanics (List separately in addition to codes for echocardiography imaging) Add on code. Use in conjunction with 93303, 93304, 93306, 90337, 93308, 93350, 93351. Report once per session. Myocardial perfusion contrast echocardiography, at rest or with
