Ultrasound Question for the Week of September 19, 2016

Question:

Question:

Our physician office will be using LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension for ultrasound exams. Do we report Q9950 for the LUMASON®?

Answer:

Answer:

Yes, as of January 1, 2016, all localities and types of facilities use Q9950 (injection, sulfur hexafluoride lipid microspheres, per mL).

LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension

INDICATIONS AND USAGE
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

CONTRAINDICATIONS
LUMASON is contraindicated in patients with:

  • Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
  • History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

IMPORTANT SAFETY INFORMATION:

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)].

Please see full Prescribing Information including boxed WARNING at http://imaging.bracco.com/us-en/lumason

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.