Given Imaging Announces CMS Assignment of an Ambulatory Payment Classification for Medicare Outpatient Use of Capsule Endoscopy
5 November 2002 - ATLANTA -- Given Imaging, Inc. (NASDAQ: GIVN) announced today that CMS (Centers for Medicare & Medicaid Services) has established an Ambulatory Payment Classification (APC) for Capsule Endoscopy for U.S. Medicare patients in an outpatient hospital setting. Ambulatory Payment Classification (APC) represents a unit of payment for Medicare hospital outpatient services. The APC reimbursement rate of $625 covers the M2A capsule and the hospital’s operating costs related to the provided service. It does not include the physician fee which is covered by a separate G Code. CMS is expected to release the physician fee schedule related to the G code before the end of the year. The final rule will become effective January 1, 2003, following a standard 60-day comment period.
"The issuance of an APC assignment further validates that capsule endoscopy is the recommended standard of care for diagnosing small bowel disorders," said Gavriel D. Meron, President and CEO of Given Imaging Ltd. "In addition to existing reimbursement statements on Capsule Endoscopy from 20 Medicare providers representing 15.2 million lives, based on today’s news we expect additional state and local Medicare providers to offer this procedure in order to provide best practice medicine to all of their covered patients. Todays decision reflects the support of respected organizations like the ASGE who help their members deliver effective and affordable treatments to patients."
Capsule Endoscopy is classified under New Technology-Level VI, APC 0711. At this time, payment is subject to local guidelines for indications and coverage which have been established in 20 states. The local guidelines include indications/diagnoses for use. For additional information please see Given Imaging’s reimbursement fact sheet at http://www.givenimaging.com/usa/reimbursement.asp Editor's Note: This link is no longer active.
"The broad acceptance of Capsule Endoscopy by gastroenterologists around the world has validated the clinical significance of this diagnostic platform for diseases of the small intestine." said Dr. David Carr-Locke, President of the American Society for Gastrointestinal Endoscopy. "We are pleased that CMS has recognized the improved patient management that results from the appropriate use of Capsule Endoscopy."
About ASGE
The American Society for Gastrointestinal Endoscopy (ASGE), founded in
1941, is the preeminent professional organization dedicated to
advancing the practice of Endoscopy. ASGE promotes the highest
standards for endoscopic training and practice, fosters endoscopic
research, recognizes distinguished contributions to Endoscopy, and is
the foremost resource for endoscopic education. ASGE, with more than
7,500 physician members worldwide, serves the medical profession and
the public by developing and advocating responsible positions for the
benefits of patients, the public and medical professionals. ASGE
publishes the leading peer-reviewed endoscopic journal,
Gastrointestinal Endoscopy (GIE), as well as a comprehensive member
newsletter, ASGE News. More information about ASGE can be found on its
Web site at www.asge.org.
This press release contains forward-looking statements, including projections about our business, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," "intends" and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, and other risks disclosed in our filings with the U.S. Securities Exchange Commission.
19.Sept.'03