Mauna Kea Technologies Announces Publication of U.S. CPT® Codes and Related Reimbursement Rates for Cellvizio® Procedures in the Upper GI Tract

Regulatory News :

Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263) (Paris:MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, today announced that the Centers for Medicare and Medicaid Services (CMS) released the hospital outpatient payment rates for the 2013 Current Procedural Terminology (CPT®) codes that will be used with Cellvizio procedures in the upper gastrointestinal tract beginning January 1, 2013.

The Category I CPT procedure codes issued by the American Medical Association (AMA) and supported by the medical societies, include 43206 for adding Cellvizio imaging to endoscopies specifically in the esophagus and 43252 for the entire upper GI tract. The CMS fee schedule indicates that Cellvizio procedures in the esophagus or the rest of the upper GI tract be reimbursed at an average payment rate of $927 per outpatient visit under Ambulatory Payment Classification (APC) 419. Physicians may also use these same codes to describe their services. Based on the documentation submitted with the claim and the value of similar services Medicare Administrative Contractors (MACs) will determine the appropriate payment amount.

"We are very pleased that AMA and CMS have created new codes to describe Cellvizio, which is recognized to be an important tool to manage patients with diseases of the gastrointestinal tract, and in particular in the esophagus,” said Sacha Loiseau, PhD, Founder and CEO of Mauna Kea Technologies. "We believe that the new codes will ease and streamline the claims processing burden for hospital outpatient departments, facilitate payment timing and increase the predictability of hospital payments for upper GI Cellvizio procedures.

About CPT Codes

CPT codes are the most widely accepted form of medical nomenclature used to report medical procedures and services under public and private health insurance programs in the U.S. APCs are the U.S. government's method of paying for facility outpatient services for the Medicare program.

The purpose of the CPT codes is to provide a uniform language that accurately describes medical, surgical, and diagnostic services. Physicians, hospitals, and other health care providers use CPT codes to report medical services to private and public health insurance systems for purposes of reimbursement. A standard system of coding also allows for reliable nationwide data collection.

Among the AMA's stated criteria for a new Category I CPT code are requirements that: (1) the service/procedure has received clearance from the U.S. Food and Drug Administration for the specific use of devices or drugs; (2) the service/procedure is a distinct service performed by many physicians/practitioners across the U.S.; (3) the clinical efficacy of the service/procedure is well established and documented in U.S. peer review literature; and (4) the service/procedure is neither a fragmentation of an existing procedure/service nor currently reportable by one or more existing codes.

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company dedicated to the advent of optical biopsy. The company researches, develops and markets innovative tools to visualize and detect cellular abnormalities during endoscopic procedures. Its flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multicenter clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI tract, biliary and pancreatic ducts and lungs.

For more information about Mauna Kea Technologies, visit www.maunakeatech.com