Ultrasound Question for the Week of January 23, 2017

Question:

Question:

The hospital outpatient prospective payment system (OPPS) Addendum B includes a new separately payable imaging procedure code C9744 for ultrasound of the abdomen with contrast, which became effective October 1, 2016.

Is the contrast they are referring to oral or must it be intravenous (IV), such as is required for computed tomography (CT) and magnetic resonance imaging (MRI)?

Answer:

Answer:

It is IV contrast. In March 2016, the Food & Drug Administration (FDA) approved LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use, Bracco’s echocardiogram contrast, for use in abdominal ultrasound for characterization of focal liver lesions. Bracco requested a code for abdominal ultrasound with contrast. LUMASON® also would be billed with HCPCS code Q9950 (injection, sulfur hexafluoride lipid microspheres, per ml). LUMASON® has pass-through status under OPPS and will be separately paid.

LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:
• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms
• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients

CONTRAINDICATIONS1
LUMASON is contraindicated in patients with:
• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)].

• Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)].
• Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

LUMASON is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Bracco Suisse S.A., Plan-les-Ouates Geneve, Switzerland (LUMASON lyophilized powder vial-25 mg lipid-type A/60.7 sulfur hexafluoride gas); Vetter Pharma-Fertigung GmbH & Co. KG, 88212 Ravensburg, Germany (Sodium Chloride 0.9% Injection, USP); B. Braun Melsungen AG, 34212 Melsungen, Germany (Mini-Spike).

LUMASON is a registered trademark of Bracco Diagnostics Inc.