Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a global leading company in the diagnostic imaging business, announced that the Centers for Medicare & Medicaid Services (CMS) has approved the request for coverage and coding for liver and/or abdominal ultrasound with contrast under the Hospital Outpatient Prospective Payment System (HOPPS).
Effective October 1, 2016, liver and/or abdominal ultrasound procedures with contrast can be assigned Healthcare Common Procedure Coding System (HCPCS) code C9744, when performed in the hospital outpatient setting.
“Obtaining approval for coding and coverage for contrast enhanced ultrasound is a milestone in the evolution of ultrasound in radiology,” said Vittorio Puppo, president and CEO, Bracco Diagnostics Inc. “The U.S. FDA’s approval of Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension for the characterization of focal liver lesions on March 31, 2016 enabled us to proceed with a submission for a new technology service for ultrasound of the liver and/or abdomen with contrast.”
“This approval demonstrates Bracco’s leadership and commitment to the imaging community across imaging modality service lines,” said Fulvio Renoldi Bracco, head of global business unit imaging at Bracco Imaging. “We are proud to be a leader in contrast imaging and delivery systems and of our continuous investment in imaging activities to help improve patient care in the U.S.”
Lumason, which has been marketed as SonoVue for over 14 years in more than 40 countries, is a contrast agent made up of gas-filled microspheres that reflect sound waves to enhance the image in ultrasonography. With a proven safety and efficacy profile in echocardiography and ultrasonography of the liver, Lumason is packaged in a convenient three-part kit that does not require refrigeration or mechanical agitation. Each kit includes a Lumason vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace; a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent); and a Mini-Spike.1
In late 2015, CMS granted “pass-through” status for Lumason reimbursement, under the HOPPS. Contrast material is not separately paid by Medicare for outpatient hospitals under outpatient prospective payment systems unless the product has “pass-through” status. This additional payment is unique to Lumason among contrast agents used in ultrasound procedures.
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
- 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
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) [Warnings and Precautions (5.1)].1
About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world’s leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.
Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers. The diagnostic imaging portfolio is completed by a range of medical devices and advanced administration systems for contrast imaging products.
1 Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; March, 2016.
(Source: PR Newswire)