BEDFORD, Mass.–(BUSINESS WIRE)–August 23, 2017–
Augmenix, Inc., a medical technology company that develops, manufactures and sells absorbable hydrogels that separate and protect organs at risk during radiotherapy, today announced that Palmetto GBA, LLC, the Medicare Administrative Contractor (MAC) covering North Carolina, South Carolina, Virginia and West Virginia will establish coverage for SpaceOAR® hydrogel when medically necessary, effective October 2, 2017. The change will enable Medicare beneficiaries in these states access to SpaceOAR hydrogel for use in prostate cancer radiotherapy.
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SpaceOAR hydrogel separates the prostate and rectum during radiation treatment (Graphic: Business Wire)
Palmetto posted a revision to its Local Coverage Determination (LCD) Non-Covered Category III CPT Codes (L34555) deleting American Medical Association (AMA) CPT® code 0438T, Transperineal placement of biodegradable material, indicating that this is now a covered procedure effective 10/02/2017.1 Currently, AMA CPT code 0438T is typically the AMA CPT code used to report the SpaceOAR hydrogel procedure.
SpaceOAR hydrogel reduces rectal injury in men receiving prostate cancer radiation therapy by acting as a spacer – pushing the rectum away from the prostate. This space between organs decreases the radiation dose to the rectum and other Organs at Risk (OAR). Earlier this year, Augmenix announced published data from their prospective, randomized clinical trial showing that patients treated with SpaceOAR hydrogel prior to prostate cancer radiotherapy demonstrated significant rectal (bowel), urinary, and sexual benefit through three years of follow up.
“Palmetto’s decision demonstrates remarkable progress in enabling patient access to SpaceOAR hydrogel, which reduces the risks associated with prostate cancer radiation therapy, including radiation proctitis, incontinence, and loss of sexual function,” said John Pedersen, CEO of Augmenix. “With the new AMA Category I CPT code previously announced and a growing body of published long-term clinical data, we anticipate significantly expanded patient access to SpaceOAR hydrogel.”
In November 2016, the AMA created a new Category I CPT Code for the SpaceOAR hydrogel procedure that will become effective on January 1, 2018. The new code will replace AMA CPT code 0438T.
About SpaceOAR Hydrogel
Radiation therapy in the treatment of prostate cancer can cause unintended radiation injury to adjacent healthy tissue (organs at risk). This injury can lead to a range of bowel, urinary and sexual symptoms that can affect patient health and quality of life during radiotherapy, and for years afterward. In recent years, radiation oncologists have considered use of “spacing” techniques to reduce the risk of radiation injury to surrounding tissue during radiotherapy. SpaceOAR hydrogel is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR hydrogel is injected as a liquid into the space between the prostate and rectum where it pushes the structures apart and then solidifies into a soft hydrogel. The hydrogel remains stable for three months during radiation therapy then liquefies and is completely absorbed by the body. See the Instructions for Use for complete information on potential risks, warnings and precautions.
About Augmenix, Inc.
Augmenix, Inc. is a privately held U.S. company based in the Boston, Massachusetts area focused on the development and commercialization of radiation oncology products using its proprietary hydrogel technology. Focusing initially on protection during prostate radiation therapy, Augmenix next-generation products will address spacing and marking applications throughout the body to improve radiotherapy and interventional oncology procedure outcomes. The company’s lead product, SpaceOAR System, is FDA cleared and is currently being used in the majority of leading cancer centers in the United States. It is also CE marked, approved in Australia and licensed in Canada. SpaceOAR is a registered trademark of Augmenix, Inc. More information about Augmenix and the SpaceOAR hydrogel can be found at http://www.Augmenix.com.
CPT® is a registered trademark of the American Medical Association
EILEEN GARDNER, RN, 781-902-1625