Welcome!

News Feed Item

The Centers For Medicare & Medicaid Services (CMS) Approved Coverage And Coding For Abdominal Ultrasound With Contrast Under The Hospital Outpatient Prospective Payment System (HOPPS) Effective October 1, 2016

MONROE TOWNSHIP, N.J., Sept. 23, 2016 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a global leading company in the diagnostic imaging business, today announced that the CMS has approved the request for coverage and coding for liver and/or abdominal ultrasound with contrast under the 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.

Bracco Diagnostics Inc. (PRNewsFoto/Bracco Diagnostics Inc.)

"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.

Please see Important Safety Information below.

About LUMASON

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

  • 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)].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.

For additional information about Bracco's products, and for full prescribing information, please visit http://imaging.bracco.com/us-en. If you have any questions or require additional information about any Bracco product, please contact Bracco Professional Services at 1-800-257-5181, option 2. 

LUMASON is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Bracco Suisse SA, 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).

SonoVue is a registered trademark of Bracco Suisse S.A.
LUMASON is a registered trademark of Bracco Diagnostics Inc.

1.LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; March, 2016.

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.

The Company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.

Operational investments have been made in order to achieve top quality, compliant and sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.

Bracco Imaging is an innovative Research and Development (R&D) structure with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centers located in Italy, Switzerland, and the USA.

To learn more about Bracco Imaging, visit www.braccoimaging.com.

Press Contact: 
Kimberly Gerweck
Bracco Diagnostics Inc.
[email protected]
609.514.2249

All trademarks and registered trademarks are the property of their respective owners.

Logo - http://photos.prnewswire.com/prnh/20160201/327852LOGO

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/the-centers-for-medicare--medicaid-services-cms-approved-coverage-and-coding-for-abdominal-ultrasound-with-contrast-under-the-hospital-outpatient-prospective-payment-system-hopps-effective-october-1-2016-300331862.html

SOURCE Bracco Diagnostics Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walk you through how Oct...
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Businesses are struggling to manage the information flow and interactions between all of these new devices and things jumping on their network, and the apps and IT systems they control. The data businesses gather is only helpful if they can do something with it. In his session at @ThingsExpo, Chris Witeck, Principal Technology Strategist at Citrix, will discuss how different the impact of IoT will be for large businesses, expanding how IoT will allow large organizations to make their legacy ap...
Adobe is changing the world though digital experiences. Adobe helps customers develop and deliver high-impact experiences that differentiate brands, build loyalty, and drive revenue across every screen, including smartphones, computers, tablets and TVs. Adobe content solutions are used daily by millions of companies worldwide-from publishers and broadcasters, to enterprises, marketing agencies and household-name brands. Building on its established design leadership, Adobe enables customers not o...
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said “No to LUNs.” With Tintri they mana...
SYS-CON Events announced today that Numerex Corp, a leading provider of managed enterprise solutions enabling the Internet of Things (IoT), will exhibit at the 19th International Cloud Expo | @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Numerex Corp. (NASDAQ:NMRX) is a leading provider of managed enterprise solutions enabling the Internet of Things (IoT). The Company's solutions produce new revenue streams or create operating...
24Notion is full-service global creative digital marketing, technology and lifestyle agency that combines strategic ideas with customized tactical execution. With a broad understand of the art of traditional marketing, new media, communications and social influence, 24Notion uniquely understands how to connect your brand strategy with the right consumer. 24Notion ranked #12 on Corporate Social Responsibility - Book of List.
Major trends and emerging technologies – from virtual reality and IoT, to Big Data and algorithms – are helping organizations innovate in the digital era. However, to create real business value, IT must think beyond the ‘what’ of digital transformation to the ‘how’ to harness emerging trends, innovation and disruption. Architecture is the key that underpins and ties all these efforts together. In the digital age, it’s important to invest in architecture, extend the enterprise footprint to the cl...
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the a...
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
DevOps and microservices are permeating software engineering teams broadly, whether these teams are in pure software shops but happen to run a business, such Uber and Airbnb, or in companies that rely heavily on software to run more traditional business, such as financial firms or high-end manufacturers. Microservices and DevOps have created software development and therefore business speed and agility benefits, but they have also created problems; specifically, they have created software sec...
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lea...