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ImpediMed Announcement: North Carolina Legislation Breaks New Ground Specifying Mandated Cover for Lymphoedema Diagnosis, Evaluation & Treatment

Tuesday, 28 July 2009
ImpediMed Announcement: North Carolina Legislation Breaks New Ground Specifying Mandated Cover for Lymphoedema Diagnosis, Evaluation & Treatment

28 July, 2009: ImpediMed Limited Chief Executive Officer Greg Brown today announced that “The General Assembly for the state of North Carolina in the US has ratified House Bill 535 of Session 2009, mandating that every health benefit plan shall provide coverage for the diagnosis, evaluation, and treatment of lymphoedema.”

Mr Brown said, ”This is ground breaking legislation that goes further than any other US federal or state legislation has previously gone. It specifically addresses coverage for the diagnosis and evaluation of lymphoedema in all situations, not just to mastectomy related lymphoedema.

“This legislation should further facilitate the adoption of a pre-emptive care approach to monitoring patients at risk of lymphoedema, by supporting medical providers in the reimbursement for the diagnosis and evaluation of lymphoedema. ImpediMed’s LDexTM product is used as an aid in the clinical assessment of patients at risk of lymphoedema. We feel this legislation strengthens the position for medical providers to be covered under the present miscellaneous code currently in use, until a category one code can be established.

“Not only does this legislation support North Carolina medical providers today in adopting ImpediMed’s technology for use with patients at risk of lymphoedema through breast cancer treatment, it also begins to pave the way for reimbursement for patients at risk of lymphoedema through pelvic region cancers, for which the patient numbers are considerably higher than breast cancer.

“With respect to the pelvic region cancer focus, ImpediMed expects to submit applications for FDA clearance of its L-Dex U400 device for use in the clinical assessment of unilateral leg lymphoedema by the 3rd quarter of 2010, and for use in the clinical assessment of bilateral leg lymphoedema by the 1st quarter of 2011.”

Mr Brown concluded, “This legislation is a very positive confirmation that lymphoedema is a major healthcare issue that needs to be addressed. It also highlights the importance of better standardised metrics for the detection and ongoing surveillance of lymphoedema and its treatments. Pre-emptive care models have been proven to be successful in preventing the progression of lymphoedema in breast cancer patients and are suspected to be equally important in pelvic cancers. The expansion of the L-Dex U400 into leg claims will definitely be supported by this legislation.”


A copy of the signed legislation can be found at this link: http://www.ncleg.net/Sessions/2009/Bills/House/PDF/H535v4.pdf
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For further information contact
Greg Brown CEO +61 (7) 3860 3700

About ImpediMed
ImpediMed Ltd. is the world leader in the development and distribution of medical devices employing Bioimpedance Spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status. ImpediMed’s primary product range consists of a number of medical devices that aid surgeons, oncologists, therapists and radiation oncologists in the clinical assessment of patients for the potential onset of secondary lymphoedema. Pre-operative clinical assessment in breast cancer survivors, before the onset of symptoms, may prevent the condition from becoming a lifelong management issue and thus improve the quality of life of the cancer survivor. ImpediMed had the first medical device with an FDA clearance in the United States to aid health care professionals in the clinical assessment of secondary lymphoedema of the arm in female breast cancer patients. For more information, visit. www.impedimed.com.